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## Protocol Section
### Identification Module
**NCT ID:** NCT06447168
**Acronym:** ELFINITY
**Brief Title:** A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
**Official Title:** Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
#### Organization Study ID Info
**ID:** CLIN-60190-461
#### Organization
**Class:** INDUSTRY
**Full Name:** Ipsen
### Status Module
#### Completion Date
**Date:** 2029-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ipsen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.
The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.
In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 24 months.
### Conditions Module
**Conditions:**
- Primary Biliary Cholangitis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 424
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.
**Measure:** Percentage of participants with response to treatment
**Time Frame:** At month 6
#### Secondary Outcomes
**Measure:** Percentage of participants with normalization of ALP levels
**Time Frame:** At months 3, 6, 12, 18 and 24
**Description:** Defined as ALP\<1.67 x ULN and TB≤ULN and ALP decrease ≥15% from baseline.
**Measure:** Percentage of participants with response to treatment
**Time Frame:** At months 3, 12, 18 and 24
**Measure:** Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of TB
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Conjugated (direct) bilirubin
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of creatinine
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of albumin
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PBC Itch score is a simple, self-administered Patient Reported Outcome (PRO) questionnaire that measures itch intensity. It uses 7-day recall periods and asks participants to rate the intensity of their worst itch over the past 7-day period on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
**Measure:** Change from baseline in pruritus based on PBC Itch score
**Time Frame:** Monthly during 24 months.
**Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. It is a subset of the longer (47-item) Functional Assessment of Cancer Therapy - Anemia (FACT-An), which includes the 27-item FACT-G and a 20-item subscale addressing additional concerns associated with the anemia of cancer and its treatment. This 20-item subscale, referred to as the anemia subscale, is comprised of 13-items that assess fatigue and its impact (the FACIT-Fatigue) and, 7 additional symptoms associated with anemia (e.g. shortness of breath, headache). participants rate their symptoms over the preceding seven days on a verbal response scale, the options range from 'not at all' / 'a little bit' / 'somewhat quite a bit' / very much'.
**Measure:** Change from baseline in fatigue based on functional assessment of chronic illness therapy-fatigue (FACIT-Fatigue) scale
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PSQI was designed to evaluate overall sleep quality in the psychiatric disorders associated with sleep disturbances. Each of the questionnaire's 19-self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored.
**Measure:** Change from baseline in sleep based on Pittsburgh sleep quality index (PSQI)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PBC-40 is a validated, PBC-specific, health-related Quality Of Life (QoL) questionnaire with 40 questions that assesses symptoms across six domains: fatigue, emotional and social, cognitive function, general symptoms and itch. Participants respond on a verbal response scale, depending on the section options range from 'never' / 'not at all' / 'strongly disagree' to 'always' / 'very much'/ 'strongly agree'. Five items (3/3 in the itch domain and 2/10 in the social domain) also include a 'does not apply' option. A score for each domain is provided (but a total score is not calculated), with each verbal response scale correlating to a score of 1-5 per item (0-5 on items with a 'does not apply' option) with 5 being the most affected.
**Measure:** Change from baseline in Quality Of Life (QoL) based on PBC-40 questionnaire
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The 5-D Itch scale assesses symptoms in terms of five domains: degree, duration, direction, disability and distribution. It is a 1 to 5 scale, with 5 being the most affected.
**Measure:** Change from baseline in QoL based on 5-Dimensional Itch scale (5-D Itch, also known as 5-D pruritus scale)
**Time Frame:** At months 3, 6, 12, 18 and 24
**Description:** Measured by transient elastography (FibroScan®) and enhanced liver fibrosis (ELF) test
**Measure:** Change from baseline in liver stiffness
**Time Frame:** At months 12 and 24.
**Description:** An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
**Measure:** Percentage of participants experiencing Adverse Events (AEs), Adverse Events of Special Interests (AESIs) and special situations (SS).
**Time Frame:** From baseline to up to 24 months.
**Description:** Measured by treatment satisfaction questionnaire for medication (TSQM). The TSQM (version 1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14).
**Measure:** Participant's satisfaction on treatment
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** Adherence to the treatment will be measured based on the participant report of missed doses every month.
**Measure:** Participant's adherence to treatment
**Time Frame:** Every month during 24 months.
**Description:** Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants with clinically significant changes in laboratory parameters
**Time Frame:** From baseline to up to 24 months.
**Description:** Clinically significant changes in physical examination will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants with clinically significant changes in physical examination
**Time Frame:** From baseline to up to 24 months.
**Description:** Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants developing clinically significant changes in vital signs
**Time Frame:** From baseline to up to 24 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant naïve to elafibranor, for whom the treating physician has decided to start treatment with elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant who started elafibranor treatment before baseline visit.
* Participant is currently participating in, plans to participate in or has participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives of the drug/active substance, whichever is longer, prior to baseline visit.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ipsen Clinical Study Enquiries
**Phone:** See e mail
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ipsen
**Name:** Ipsen Medical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
**IPD Sharing:** YES
**Time Frame:** Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
**URL:** https://vivli.org/members/ourmembers/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000002780
- Term: Cholestasis, Intrahepatic
- ID: D000002779
- Term: Cholestasis
- ID: D000008107
- Term: Liver Diseases
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000005355
- Term: Fibrosis
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6002
- Name: Cholangitis
- Relevance: HIGH
- As Found: Cholangitis
- ID: M11105
- Name: Liver Cirrhosis, Biliary
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: LOW
- As Found: Unknown
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6019
- Name: Cholestasis
- Relevance: LOW
- As Found: Unknown
- ID: M6020
- Name: Cholestasis, Intrahepatic
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: T4683
- Name: Primary Biliary Cholangitis
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
### Condition Browse Module - Meshes
- ID: D000002761
- Term: Cholangitis
- ID: D000008105
- Term: Liver Cirrhosis, Biliary
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447155
**Brief Title:** Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
**Official Title:** The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
#### Organization Study ID Info
**ID:** IstanbulTRH-DArman-003
#### Organization
**Class:** OTHER_GOV
**Full Name:** Istanbul Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Istanbul Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Istanbul Training and Research Hospital
**Investigator Full Name:** DİDEM ARMAN
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).
While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH.
The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.
**Detailed Description:** Objectives: The investigators aimed to evaluate the clinical consequences of different types of enteral nutrition during TH in babies with HIE.
Methods: This single-center, prospective randomized controlled trial (RCT) was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital. A cohort of 60 infants with HIE, born at 35 0/7 to 42 6/7 weeks of gestation who received TH were enrolled.
The infants enterally fed with bolus feeding during hypothermia (n =20), those who were fed continuously (n=20) constituted the study groups. The control group (n =20) was composed of neonates who were not fed. Infants were monitored for clinical consequences such as feeding intolerance, time to full enteral feeding, duration of hospitalization, necrotizing enterocolitis and mortality.
### Conditions Module
**Conditions:**
- Hypoxic Ischemic Encephalopathy of Newborn
- Feeding Patterns
**Keywords:**
- Newborn
- Hypoxic ischemic encephalopathy
- Enteral feeding
- Bolus
- Continuous
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Care provider decides the type of feeding according to the randomization list which were prepared via a website (http://www.randomizer.org)
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Bolus feeding
**Label:** The babies fed with bolus feeding during TH
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Continuous feeding
**Label:** The babies fed with continuous feeding during TH
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** The babies who were not fed
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The babies fed with bolus feeding during TH
**Description:** The babies fed with bolus feeding during TH composed this group
**Name:** Bolus feeding
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- The babies fed with continuous feeding during TH
**Description:** The babies fed with continuous feeding during TH composed this group
**Name:** Continuous feeding
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- The babies who were not fed
**Description:** The babies who were not fed during TH composed this group
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The infants will be monitorized for NEC development
**Measure:** Development of Necrotizing enterocolitis (NEC)
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
#### Secondary Outcomes
**Description:** The infants will be monitorized for feeding intolerance
**Measure:** Feeding intolerance
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
**Description:** The infants will be monitorized for feeding intolerance
**Measure:** Time to full enteral feeding
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit \&gt;-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \&amp; Sarnat classification based on neurological examination were treated with TH.
Exclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.
-
**Maximum Age:** 1 Day
**Minimum Age:** 0 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** DİDEM ARMAN
**Phone:** 05056211989
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** IstanbulTRH
### IPD Sharing Statement Module
**Description:** The data sets generated during and/or analyzed during current study may be available from the corresponding author on reasonable request.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854. Erratum In: N Engl J Med. 2010 Mar 18;362(11):1056.
**PMID:** 19797281
**Citation:** Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
**PMID:** 23440789
**Citation:** Martin-Ancel A, Garcia-Alix A, Gaya F, Cabanas F, Burgueros M, Quero J. Multiple organ involvement in perinatal asphyxia. J Pediatr. 1995 Nov;127(5):786-93. doi: 10.1016/s0022-3476(95)70174-5.
**PMID:** 7472837
**Citation:** Sharma S, Kallesh A, Aradhya AS, Diggikar S, Veeraiah PS, Subbareddy NN, Walikar S, Reddy IV, Sarji D, Venkatagiri P. Feasibility of Minimal Enteral Nutrition During Therapeutic Hypothermia for Perinatal Asphyxia: A Five-Year Multicenter Experience from South India. Indian J Pediatr. 2023 May;90(5):513-515. doi: 10.1007/s12098-022-04456-x. Epub 2023 Jan 16.
**PMID:** 36642779
**Citation:** Kumar J, Anne RP, Meena J, Sundaram V, Dutta S, Kumar P. To feed or not to feed during therapeutic hypothermia in asphyxiated neonates: a systematic review and meta-analysis. Eur J Pediatr. 2023 Jun;182(6):2759-2773. doi: 10.1007/s00431-023-04950-0. Epub 2023 Apr 4.
**PMID:** 37014443
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000002534
- Term: Hypoxia, Brain
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5794
- Name: Brain Ischemia
- Relevance: HIGH
- As Found: Ischemic Encephalopathy
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxic
- ID: M10085
- Name: Hypothermia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: HIGH
- As Found: Encephalopathy
- ID: M22660
- Name: Hypoxia-Ischemia, Brain
- Relevance: HIGH
- As Found: Hypoxic Ischemic Encephalopathy
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5783
- Name: Hypoxia, Brain
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001927
- Term: Brain Diseases
- ID: D000002545
- Term: Brain Ischemia
- ID: D000020925
- Term: Hypoxia-Ischemia, Brain
- ID: D000007511
- Term: Ischemia
- ID: D000000860
- Term: Hypoxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447142
**Brief Title:** The Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises in Degenerative Meniscus Tears
**Official Title:** Comparison of the Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises on Pain, Function, and Health-related Quality of Life in Degenerative Meniscus Tears
#### Organization Study ID Info
**ID:** 2133
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-10-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Tansu Birinci
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.
**Detailed Description:** Patients with degenerative meniscus tears between the ages of 40 and 65 will be randomly divided into two groups: Group 1 (open kinetic chain strengthening exercises) and Group 2 (closed kinetic chain strengthening exercises). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).
### Conditions Module
**Conditions:**
- Degenerative Disease
- Meniscus Tear
- Knee Pain Swelling
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject in Group 1 will receive a treatment protocol consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip.
**Intervention Names:**
- Other: Open kinetic chain strengthening exercise
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip.
**Intervention Names:**
- Other: Closed kinetic chain strengthening exercise
**Label:** Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
**Description:** A web-based 8-week exercise program consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
**Name:** Open kinetic chain strengthening exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 2
**Description:** A web-based 8-week exercise program consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
**Name:** Closed kinetic chain strengthening exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** At the end of 8-week intervention
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** Baseline
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** At the end of 8-week intervention
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** Baseline
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** At the end of 8-week intervention
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** Baseline
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** At the end of the 8-week intervention
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** Baseline
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** At the end of the 8-week intervention
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** Baseline
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** At the end of the 8-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Being aged between 40 and 65 years Having the degenerative meniscus tear in at least one knee Having body mass index in the range of 18-30 kg/m2 Feeling the pain that lasts for at least 2 months Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results Having the ability to read and write Turkish
Exclusion Criteria:
Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks Have received steroid injections in the last 6 months Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis Presence of any systemic disorder that may affect assessment parameters Failure to cooperate with assessments
**Maximum Age:** 65 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tansu Birinci, PT, PhD
**Phone:** 02162803333
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul University-Cerrahpasa
**State:** Bakırkoy
**Zip:** 34147
#### Overall Officials
**Official 1:**
**Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Name:** Tansu Birinci, PT, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447129
**Brief Title:** Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
**Official Title:** Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 216
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-10-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Tansu Birinci
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.
**Detailed Description:** To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (Exercise with NMES) and Group 2 (Exercise). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).
### Conditions Module
**Conditions:**
- Degenerative Disease
- Meniscus Tear
- Knee Pain Swelling
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip, and NMES application for the quadriceps femoris muscle.
**Intervention Names:**
- Other: Exercise
- Other: Neuromuscular electrical stimulation
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip.
**Intervention Names:**
- Other: Exercise
**Label:** Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
- Group 2
**Description:** An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed.
The patients will do exercises under the control of the physiotherapist in the clinic.
The patient will perform the exercises with the verbal and visual commands of the physiotherapist.
**Name:** Exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 1
**Description:** The Neuromuscular Electrical Stimulation (NMES) will be applied for 20 minutes. The patient will be seated with hips and knees flexed at 90°. Electrodes will be placed on the proximal and distal ends of the vastus medialis obliquus and vastus lateralis muscles. The intensity will be increased as much as the patient can tolerate, and the patient will be asked to relax and not make voluntary muscle contractions.
**Name:** Neuromuscular electrical stimulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** At the end of 8-week intervention
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** Baseline
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** At the end of 8-week intervention
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** Baseline
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** At the end of 8-week intervention
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** Baseline
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** At the end of the 8-week intervention
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** Baseline
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** At the end of the 8-week intervention
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** Baseline
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** At the end of the 8-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Being aged between 40 and 65 years Having the degenerative meniscus tear in at least one knee Having body mass index in the range of 18-30 kg/m2 Feeling the pain that lasts for at least 2 months Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results Having the ability to read and write Turkish
Exclusion Criteria:
Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks Have received steroid injections in the last 6 months Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis Presence of any systemic disorder that may affect assessment parameters Failure to cooperate with assessments
**Maximum Age:** 65 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ebru Kaya Mutlu, PT, PhD
**Phone:** 0 266 717 0117
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tansu Birinci, PT, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ebru Kaya Mutlu, PT, PhD
- **Phone:** 0 266 717 0117
- **Role:** CONTACT
***Contact 3:***
- **Name:** Abdullah Yahya Okur, PT, MSc
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Ebru Kaya Mutlu, PT, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Tansu Birinci, PT, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 6:***
- **Name:** Nezih Ziroğu, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** Istanbul University-Cerrahpasa
**State:** Bakırkoy
**Zip:** 34147
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447116
**Brief Title:** An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in Acute Ischemic Stroke.
**Official Title:** An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke.
#### Organization Study ID Info
**ID:** CIP 004
#### Organization
**Class:** OTHER
**Full Name:** Jacobs institute
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jacobs institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.
**Detailed Description:** A prospective, single-arm, open-label, nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime™ Carotid Stent in adults (18 years of age or older) with extracranial stenosis in the setting as an acute ischemic stroke.
### Conditions Module
**Conditions:**
- Acute Ischemic Stroke
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** CGuard Prime™ Carotid Stent System
**Name:** CGuard Prime™ Carotid Stent System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of subjects with mRS ≤ 2 at 90 days
**Measure:** Proportion of subjects with mRS ≤ 2 at 90 days
**Time Frame:** 90 days
#### Secondary Outcomes
**Description:** Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.
**Measure:** Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) \>/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).
Exclusion Criteria:
* Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS\<6; and any contraindication to dual antiplatelet therapy.
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
- ID: D000007238
- Term: Infarction
- ID: D000009336
- Term: Necrosis
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M10282
- Name: Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000002544
- Term: Cerebral Infarction
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447103
**Brief Title:** An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
**Official Title:** 89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
#### Organization Study ID Info
**ID:** 23-001576
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-01928
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2030-06-01
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Telix Pharmaceuticals (Innovations) Pty Limited
#### Lead Sponsor
**Class:** OTHER
**Name:** Jonsson Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To compare the lesion detection rate (i.e., positivity rate per patient) of zirconium Zr 89 girentuximab (89Zr-DFO-GmAb) PET/CT compared to the standard of care diagnostic contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded independent central review (BICR).
SECONDARY OBJECTIVES:
I. To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk imaged in the post-nephrectomy or metastasectomy setting.
II. To compare the positive predictive value (PPV) of 89Zr-DFO-GmAb PET/CT in patients with available lesion validation by 1) histopathology (biopsy/resection), 2) evidence of growth under surveillance or 3) reduction of size under treatment, and 4) unequivocal confirmation of malignancy on a different imaging modality.
III. To assess the recurrence-free survival of individuals with/without evidence of disease based on 89Zr-DFO-GmAb PET/CT staging results (PET/CT designated M1 versus \[vs\] M0).
EXPLORATORY OBJECTIVES:
I. Correlate level of histological CAIX expression (H Score) from the primary tumor to 89Zr-TLX250 standardized uptake values (SUVs) in patients with visualized disease on 89Zr-DFO-GmAb PET/CT.
II. To identify the standardized uptake value (SUV) cut-off for 89Zr-DFO-GmAb suitable for the detection of metastatic lesions in the postoperative setting.
III. To evaluate the performance of established prognostic transcriptomic classifiers (from the nephrectomy specimen) on disease-free survival.
IV. To evaluate if circulating tumor DNA (ctDNA) for the detection of molecular residual disease (MRD) correlates with the presence of active disease seen on 89Zr-DFO-GmAb PET/CT or predicts disease-free survival.
OUTLINE:
Patients receive 89Zr-DFO-GmAb intravenously (IV) over 3 minutes on day 0 then undergo whole body PET/CT and standard of care (SOC) diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or magnetic resonance imaging (MRI) of the brain on study as clinically indicated.
After completion of study intervention, patients are followed up at 8, 16 and 24 months.
### Conditions Module
**Conditions:**
- Clear Cell Renal Cell Carcinoma
- Metastatic Clear Cell Renal Cell Carcinoma
- Recurrent Clear Cell Renal Cell Carcinoma
- Sarcomatoid Renal Cell Carcinoma
- Stage II Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8
- Stage III Renal Cell Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 91
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and SOC diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or MRI of the brain on study as clinically indicated.
**Intervention Names:**
- Procedure: Biospecimen Collection
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Other: Questionnaire Administration
- Drug: Zirconium Zr 89 Girentuximab
**Label:** Diagnostic (89Zr-DFO-GmAb PET/CT)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo blood sample collection
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo bone scan
**Name:** Bone Scan
**Other Names:**
- Bone Scintigraphy
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo CT, PET/CT, and CT of the brain
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- tomography
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo MRI of the brain
**Name:** Magnetic Resonance Imaging
**Other Names:**
- Magnetic Resonance
- Magnetic Resonance Imaging (MRI)
- Magnetic resonance imaging (procedure)
- Magnetic Resonance Imaging Scan
- Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
- MR
- MR Imaging
- MRI
- MRI Scan
- MRIs
- NMR Imaging
- NMRI
- Nuclear Magnetic Resonance Imaging
- sMRI
- Structural MRI
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo PET/CT
**Name:** Positron Emission Tomography
**Other Names:**
- Medical Imaging, Positron Emission Tomography
- PET
- PET Scan
- Positron emission tomography (procedure)
- Positron Emission Tomography Scan
- Positron-Emission Tomography
- proton magnetic resonance spectroscopic imaging
- PT
**Type:** PROCEDURE
#### Intervention 6
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Given IV
**Name:** Zirconium Zr 89 Girentuximab
**Other Names:**
- 89Zr-DFO-TFP-girentuximab
- 89Zr-girentuximab
- 89Zr-TLX250
- Zirconium Zr 89 cG250
- Zirconium Zr 89-TLX250
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patients will be treated as binary categorization as follows: (i) Patients who have ≥ 1 lesion confirmed to be recurrent disease will be designated positive (recurrence). (ii) Patients with no lesions detected will be designated negative (no recurrence). The analysis of the primary objective will utilize McNemar's test to compare the detection rate between the imaging techniques.
**Measure:** Lesion detection rate
**Time Frame:** Up to 16 weeks from surgical resection
#### Secondary Outcomes
**Description:** The total number of AEs will be summarized with grade and attribution. The total number of significant AEs will be summarized with attribution if present. AEs will be descriptive in nature and only counts and percentage will be reported.
**Measure:** Incidence of adverse events (AEs)
**Time Frame:** Up to day 14
**Description:** Will compare PPV of 89Zr-DFO-GmAb PET/CT in subjects designated as having a suspicious lesion on the BICR PET/CT evaluation, will review follow up for available lesion validation by 1) histopathology (biopsy/resection), 2) evidence of growth under surveillance or 3) reduction of size under treatment, and 4) unequivocal confirmation of malignancy on a different imaging modality. As there are no firm estimates to the number of lesions that will be designated as suspicious, there are no planned statistical analyses planned. Would present the total number of cases and the frequency of validation with the 95% confidence interval.
**Measure:** Positive predictive value (PPV)
**Time Frame:** Up to 2 years
**Description:** Recurrence-free survival will be calculated using the Kaplan-Meier Method with date and evidence of recurrence based on either clinical annotation by the treating physician or documentation of recurrence by diagnostic imaging or histopathology. Analysis will be descriptive and provide an estimated 2-year recurrence-free survival with 95% confidence interval. A Log-rank test will compare the differences in recurrence-free survival between groups.
**Measure:** Recurrence-free survival
**Time Frame:** Up to 2 years
**Description:** Questionnaires using Likert scores will be used to determine changes. Analysis will be descriptive.
**Measure:** Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)
**Time Frame:** At baseline and up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18
* Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy)
* For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study
* Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \< 2 years)
* Surgery must have been performed between 4-16 weeks at the time of planned imaging
* Subjects are considered to have a high risk of recurrence based on the following criteria:
* Intermediate-high risk ccRCC:
* pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0
* pathologic tumor stage 3 (pT3), any grade, N0, M0
* High risk ccRCC:
* pathologic tumor stage 4 (pT4), any grade, N0, M0
* pT any stage, any grade, number of positive nodes (pN+), M0
* M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy
* Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \[WOCBP\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)
* Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration
* Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)
Exclusion Criteria:
* Inability to provide written informed consent
* Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
* Prior post-operative imaging for confirmation of disease status
* An untreated non-renal malignancy with the following exceptions:
* Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \[NCCN\] very low/low risk)
* Non-melanoma skin cancer
* Any prior treated malignancy meeting the following characteristics:
* Treated stage I or II cancer from which the patient is currently in complete remission
* A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment
* A hematologic malignancy from which the patient is currently in complete remission
* Contraindication to the use of iodinated contrast-enhanced CT agents, based on:
* Severe allergy (for which pre-medication cannot limit adverse reactions) or
* Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73m\^2
* Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment
* Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration
* Women who are pregnant or breastfeeding
* Known hypersensitivity to girentuximab
* Known inability to remain still and lie flat imaging procedure (about 30 minutes)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Brian Shuch
- **Phone:** 310-794-0987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Brian Shuch
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UCLA / Jonsson Comprehensive Cancer Center
**State:** California
**Zip:** 90095
#### Overall Officials
**Official 1:**
**Affiliation:** UCLA / Jonsson Comprehensive Cancer Center
**Name:** Brian Shuch
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000007680
- Term: Kidney Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5548
- Name: Carcinoma, Renal Cell
- Relevance: HIGH
- As Found: Clear Cell Renal Cell Carcinoma
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M10703
- Name: Kidney Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4906
- Name: Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Renal Cell Carcinoma
- ID: T1341
- Name: Clear Cell Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Clear Cell Renal Cell Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002292
- Term: Carcinoma, Renal Cell
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Irreversible Pulpitis
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000911
- Term: Antibodies, Monoclonal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447090
**Acronym:** VMAC+DLI
**Brief Title:** VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT
**Official Title:** Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
#### Organization Study ID Info
**ID:** IIT2024002
#### Organization
**Class:** OTHER
**Full Name:** Institute of Hematology & Blood Diseases Hospital, China
### Status Module
#### Completion Date
**Date:** 2027-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Hematology & Blood Diseases Hospital, China
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation.
The main questions it aims to answer are:
The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
**Detailed Description:** venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5)，and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10\^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.
Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.
### Conditions Module
**Conditions:**
- Relapse Acute Myeloid Leukemia
**Keywords:**
- Mitoxantrone liposome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** VMAC regimen :
Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.
**Intervention Names:**
- Drug: Mitoxantrone hydrochloride liposome
**Label:** VMAC+DLI
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VMAC+DLI
**Description:** Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.
**Name:** Mitoxantrone hydrochloride liposome
**Other Names:**
- Venetoclax
- Cytarabine,Cytosine arabinoside
- Cyclophosphamide
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
**Measure:** CRR
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks
**Measure:** PR
**Time Frame:** 1 year
**Description:** CR+PR
**Measure:** ORR
**Time Frame:** 1year
**Description:** The time from the start of treatment to death due to any reason
**Measure:** 2-year OS
**Time Frame:** 2 years
**Description:** The time from the start of treatment to disease recurrence or death from any cause
**Measure:** DFS
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
2. Age ≥18 years and ≤65 years old, regardless of gender;
3. Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
4. An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.
Exclusion Criteria:
Subjects who meet any of the following criteria shall not be enrolled in this study:
* 1) Secondary transplant patients;
* 2) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
* 3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
* 4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
* 5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
* 6) Active heart disease, definition One or more of the following:
1. Long QTc syndrome or QTc interval \>480ms;
2. Complete left bundle branch block, II or III degree atrioventricular block;
3. Need for drug treatment or History of severe arrhythmia with clinical symptoms;
4. New York Heart Association classification ≥ II;
5. Left ventricular ejection fraction less than 50%;
6. Myocardial infarction, unstable angina, severe myocardial infarction within 6 months before enrollment History of unstable ventricular arrhythmias or any other arrhythmias requiring treatment, clinically severe pericardial disease, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* 7) Transplantation from an unrelated donor;
* 8) Those deemed not suitable for enrollment by the researcher.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xin Chen, Doctor
**Phone:** 13920985705
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xueou Liu, Doctor
**Phone:** 022-23909095
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tianjin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xin Chen, Doctor
- **Phone:** 13920985705
- **Role:** CONTACT
**Country:** China
**Facility:** Institute of Hematology & Blood Diseases Hospital, China
**State:** Tianjin
**Status:** RECRUITING
**Zip:** 300000
#### Overall Officials
**Official 1:**
**Affiliation:** Institute of Hematology & Blood Diseases Hospital, China
**Name:** Xin Chen, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Relapse
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M6766
- Name: Cytarabine
- Relevance: HIGH
- As Found: Multi-
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: 15 minutes
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Move
- ID: M18961
- Name: Cyclosporine
- Relevance: LOW
- As Found: Unknown
- ID: M6730
- Name: Cyclosporins
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003561
- Term: Cytarabine
- ID: D000003520
- Term: Cyclophosphamide
- ID: C000579720
- Term: Venetoclax
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447077
**Brief Title:** Impact of Predetermined Day 5 ET vs. Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment
**Official Title:** Impact of Predetermined Day 5 Embryo Transfer vs. Predetermined Day 6 Embryo Transfer on Clinical Pregnancy Rate After Intracytoplasmic Sperm Injection (ICSI) Treatment
#### Organization Study ID Info
**ID:** ET d5 vs d6
#### Organization
**Class:** OTHER
**Full Name:** Infertility Treatment Center Dortmund
### Status Module
#### Completion Date
**Date:** 2028-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Fertility Center Dortmund
**Class:** UNKNOWN
**Name:** novum - Center for Reproductive Medicine Essen - Duisburg
**Class:** UNKNOWN
**Name:** Deutsche Klinik Bad Münder
#### Lead Sponsor
**Class:** OTHER
**Name:** Infertility Treatment Center Dortmund
#### Responsible Party
**Investigator Affiliation:** University of Witten/Herdecke
**Investigator Full Name:** Prof. Dr. Stefan Dieterle
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer, and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).
**Detailed Description:** Since a predetermined embryo transfer on day 5 cannot be performed in some centers on every day (e.g. sunday), some IVF centers perform an predetermined embryo transfer on day 4 or day 6, respepectively. Data for a predetermined embryo transfer on day 4 vs. a predetermined embryo transfer on day 5 showed no significant differences. However, since a day 6 transfer offers some advantages in assessing the development stage, the prolonged culture and transfer on day 6 transfer offers also a very promising option.
However, there are no prospective studies in the current literature examining the equivalence of a predetermined embryo transfer on day 6 vs. a predetermined embryo transfer on day 5.
The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer, and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).
### Conditions Module
**Conditions:**
- Infertility
- Reproductive Issues
**Keywords:**
- ICSI
- Predetermined Day 6 Embryo Transfer
- Predetermined Day 5 Embryo Transfer
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2400
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 9 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** The control group will include patients who have their oocyte pick-up on a Monday (embryo transfer on Saturday, day 5), Wednesday (embryo transfer on Monday, day 5), Thursday (embryo transfer on Tuesday, day 5), Friday (embryo transfer on Wednesday, day 5) and Saturday (embryo transfer on Thursday, day 5).
**Label:** Predetermined embryo transfer on day 5
#### Arm Group 2
**Description:** The study group will include patients who have their oocyte pick-up on a Tuesday (embryo transfer on Monday, day 6).
**Label:** Predetermined embryo transfer on day 6
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical pregnancy rate per embryo transfer (detection of a gestational sac)
**Measure:** Clinical pregnancy rate per embryo transfer
**Time Frame:** 4 weeks after embryo transfer
#### Secondary Outcomes
**Description:** Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy)
**Measure:** Abortion rate per clinical pregnancy
**Time Frame:** During entire ongoing pregnancy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The patients to be included should be ≥18 years old; there is no upper age limit. Only ICSI treatments with a single embryo transfer (SET) should be included. Only the first cycle per patient pair should be evaluated.
Exclusion Criteria:
none
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Female patients seeking ICSI treatment because of male subfertilit
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefan Dieterle, MD
**Phone:** 00492315575450
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tom Trapphoff, DR
**Phone:** 00492315575450
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Witten/Herdecke
**Name:** Stefan Dieterle, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10290
- Name: Infertility
- Relevance: HIGH
- As Found: Infertility
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007246
- Term: Infertility
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447064
**Acronym:** (CLOCS-2)
**Brief Title:** Cancer Loyalty Card Study 2 (CLOCS-2)
**Official Title:** Cancer Loyalty Card Study 2: a Retrospective Observational Case-Control Study
#### Organization Study ID Info
**ID:** 324742
#### Organization
**Class:** OTHER
**Full Name:** Imperial College London
### Status Module
#### Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-29
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Birmingham
**Class:** OTHER
**Name:** University of Nottingham
**Class:** OTHER
**Name:** University of Central Lancashire
**Class:** OTHER
**Name:** Cancer Research UK
**Class:** OTHER
**Name:** Imperial College Healthcare NHS Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** Imperial College London
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working.
Therefore, early diagnosis is the most important way to improve cancer outcomes.
Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person.
The major reasons for not presenting to the GP with symptoms such as these are "not wanting to waste the GP's time" and normalisation of these symptoms. The persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician.
RATIONALE FOR CURRENT STUDY An early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor.
Information about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.
**Detailed Description:** Purpose and Design The Cancer Loyalty Card Study-2 (CLOCS-2) addresses whether or not data already collected by high street retailers can detect significant changes in cancer patients' purchase behaviours before their diagnosis. The aim is to conduct a case-control study of cancer patients matched with participants without these cancer types. At least 750 recently diagnosed cancer patients and at least 750 participants as controls will be recruited and up to six years of prior purchase data will be collated.
Recruitment Participants, 18 years or older, with any of the aforementioned cancer forms and having at least one of the participating high street retailer's loyalty cards from Tesco or Boots in their household, will be recruited through the GP invites. All participants registering in the study and not holding the primary ownership of the loyalty cards from Tesco or Boots must register in the study along with the primary owner of the loyalty card from the same household. All the collected data will be safeguarded in a secure enclave with limited access to the CLOCS-2 team.
Consent All participants will be given the information sheet and consent form through a REDCap link shared through GP messages. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever convenient and fill it out online at REDCap.
Methods Loyalty card holders with primary ownership of at least one of the participating high street retailers loyalty cards from Tesco or Boots and their family members living in the same household are eligible to participate in CLOCS-2. All participants will be invited to join the study by GP invites through text messages and can choose to sign up via a link provided in invites, that leads to REDCap. People over 18 years of age and with any form of cancer as listed earlier and who use at least one of the participating high street retailer's loyalty cards in their household will be recruited as cases. Whereas people over 18 years of age, without the diagnosis of these cancer types and using at least one of the participating high street retailer's loyalty cards in their households will be recruited as control participants.
Consenting participants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. To adhere to participating high street retailers' policies, all participants will need to provide a photo ID and utility bill for ID verification. The tentative participant recruitment date is 01/09/2023. Once the participants are recruited in the study, their past six years of purchase history will be requested from Tesco/Boots from the recruitment date. This data received from these high street retailers will be non-identifiable pseudonymised data. Participant identity will be linked to the analysis datasets only through a unique barcode assigned when completing the recruitment questionnaire, meaning the data will be pseudonymised.
The only identifiable information will be on the consent form and the participant barcode. Retailer and questionnaire data will only be linked via the pseudonymised participant barcode.
If participants consent to be re-contacted by the CLOCS-2 team for future studies or loyalty card detail clarification, they can opt for it in their consent forms. No further action is needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary). Participants will be provided with the study's website and encouraged to visit the study's website for updates.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
- Colon Cancer
- Oesophageal Cancer
- Stomach Cancer
- Liver Cancer
- Bladder Cancer
- Uterine Cancer
- Vulvar Cancer
- Ovarian Cancer
- Endometrial Cancer
**Keywords:**
- Ovarian Cancer
- Epidemiology
- Observational Study
- Risk Assessment
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants diagnosed with cancer.
**Intervention Names:**
- Other: Cases & Controls
**Label:** Cases
#### Arm Group 2
**Description:** Participants not diagnosed with cancer.
**Intervention Names:**
- Other: Cases & Controls
**Label:** Controls
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cases
- Controls
**Description:** Participants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. The participant will need to provide a photo ID and utility bill for ID verification. After recruitment the participants purchase history in the past 6 years will be requested from the retailers.
**Name:** Cases & Controls
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome of the CLOCS-2 will be to define the time by which the cases and controls are statistically significantly (p≤0.05) different in their purchase behaviours leading up to a cancer diagnosis on a population level.
**Measure:** Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Defining a purchase threshold as an 'alert' about cancer symptoms in individuals and determining the predictive utility of purchasing behaviours in the early detection of these cancer forms.
**Measure:** Alert about Cancer symptoms assessed by purchase behaviour
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals, at least 18 years old, recently diagnosed and living with any of the mentioned cancer forms (colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic), diagnosed up to 2 years prior, at the latest and having loyalty card of at least one participating high street retailer in their household, are eligible to join the CLOCS-2 as cases.
* Individuals, at least 18 years old, who have not been diagnosed with any of these cancer forms and having at least one participating high street retailer loyalty card in their household, are eligible to join the CLOCS-2 as controls
Exclusion Criteria:
* Individuals under the age of 18 years.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults aged ≥18 years old, who own at least one participating high street retailer loyalty cad in their household. Among these individuals, those who have been diagnosed with any form of cancer as mentioned above (can join the CLOCS-2 as cases, and those who have no prior cancer diagnosis from the list of cancers mentioned above are eligible to join as controls.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sima Toopchiani
**Phone:** 02075942127
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dr James Flanagan
**Phone:** 02075942127
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Name:** Emily Pickford
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Imperial College Healthcare NHS Trust
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Imperial College London
**Name:** Dr James Flanagan
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000014591
- Term: Uterine Diseases
- ID: D000014845
- Term: Vulvar Diseases
- ID: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M17589
- Name: Vulvar Neoplasms
- Relevance: HIGH
- As Found: Vulvar Cancer
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Stomach Cancer
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: HIGH
- As Found: Uterine Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M19235
- Name: Endometrial Neoplasms
- Relevance: HIGH
- As Found: Endometrial Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17588
- Name: Vulvar Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T5877
- Name: Vulvar Cancer
- Relevance: HIGH
- As Found: Vulvar Cancer
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Stomach Cancer
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Oesophageal Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000016889
- Term: Endometrial Neoplasms
- ID: D000014846
- Term: Vulvar Neoplasms
- ID: D000013274
- Term: Stomach Neoplasms
- ID: D000014594
- Term: Uterine Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447051
**Brief Title:** Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.
**Official Title:** Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.
#### Organization Study ID Info
**ID:** ILBS-Biliary Atresia-01
#### Organization
**Class:** OTHER
**Full Name:** Institute of Liver and Biliary Sciences, India
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Liver and Biliary Sciences, India
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation \[1\]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level \<2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States \[2\]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents \[3,4\]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect \[5\].
In 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation \[6\]. Since then there have been multiple trial most prominent being, Kings hospital trial \[7\] and START trial \[8\] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival.
However one study done by Bezerra et al \[9\] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.
**Detailed Description:** Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
Study design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study.
Monitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year.
Statistical Analysis: Appropriate statistical test for correlation analysis will be applied.
Adverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.
### Conditions Module
**Conditions:**
- Biliary Atresia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subject undergoing Kasai Surgery at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
**Intervention Names:**
- Other: Kasai Surgery
**Label:** Biliary Atresia
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Biliary Atresia
**Description:** As per institute treatment protocol
**Name:** Kasai Surgery
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** We expect steroids used in customized manner to improve biliary drainage and thereby improve native liver survival in post kasai patients.
**Time Frame:** Within 6 months
#### Secondary Outcomes
**Measure:** Improved survival with native liver at 12 months of age.
**Time Frame:** 12 months
**Measure:** Reduced progression of portal Hypertension at 6 & 12 months
**Time Frame:** 6 & 12 months
**Measure:** Improved Growth parameters at 3, 6, 12 months
**Time Frame:** 3, 6, 12 months
**Measure:** Reduction in Bilirubin levels at 3, 6, 12 month
**Time Frame:** 3, 6, 12 months
**Measure:** Reduced PELD at 3, 6, 12 months
**Time Frame:** 3, 6, 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Post Kasai Biliary atresia operated at ILBS with retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
Exclusion Criteria:
1. Subjects having major surgical complications
2. Defaulters or Patient not following protocol/not giving consent
3. Biliary atresia splenic malformation
**Maximum Age:** 6 Months
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dr Anmol Anmol, MD
**Phone:** 01146300000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Delhi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dr Anmol, MD
- **Phone:** 01146300000
- **Role:** CONTACT
**Country:** India
**Facility:** Institute of Liver & Biliary Sciences
**State:** Delhi
**Zip:** 110070
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004065
- Term: Digestive System Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4942
- Name: Biliary Atresia
- Relevance: HIGH
- As Found: Biliary Atresia
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M7254
- Name: Digestive System Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: T757
- Name: Biliary Atresia
- Relevance: HIGH
- As Found: Biliary Atresia
### Condition Browse Module - Meshes
- ID: D000001656
- Term: Biliary Atresia
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447038
**Acronym:** NDO
**Brief Title:** Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
**Official Title:** Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
#### Organization Study ID Info
**ID:** OND 01
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario de Burgos
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitario de Burgos
#### Responsible Party
**Investigator Affiliation:** Hospital Universitario de Burgos
**Investigator Full Name:** Didier Sánchez OSpina
**Investigator Title:** Doctor investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also \"systemic damage\" (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.
**Detailed Description:** This is a protocol in which we seek to identify those patients with alterations incipient renal failure by determining the albumin/creatinine ratio in urine, test that is currently performed routinely in different groups of patients. By For this reason, the implementation of the non-dialysis objective protocol hopes to be implemented standardized form in patients who go to their primary attention doctor in the province of Burgos to later be extended to the entire Castilla y Leon community.
.
### Conditions Module
**Conditions:**
- Chronic Kidney Disease (CKD)
**Keywords:**
- Epidemiology.
- Chronic kidney disease.
- Primary care.
- Cardiovascular risk factors.
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 10 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Population of the city of Burgos \> 18 years old.
**Intervention Names:**
- Diagnostic Test: albumin creatinine ratio
**Label:** Population
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Population
**Description:** Albumin creatinine ratio, this test is routinely performed in urine.
**Name:** albumin creatinine ratio
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Determination of albuminuria in urine.
**Measure:** Albumin creatinine ratio.
**Time Frame:** 01/02/2024 al 01/12/2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Minimum age 18 years
Exclusion Criteria:
* Age less than 18 years
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Population of the city of Burgos, Spain who go to their primary doctor.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Burgos
**Country:** Spain
**Facility:** Maria J Izquierdo
**Zip:** 09003
#### Overall Officials
**Official 1:**
**Affiliation:** HUBU
**Name:** Maria J Izquierdo Ortiz, Doctor
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** HUBU
**Name:** Emilio J Gonzalez Parra, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** HUBU
**Name:** Sebastian Mas Fontao, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** HUBU
**Name:** Maria Martin Palencia, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** HUBU
**Name:** Didier Sanchez, Doctor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
**PMID:** 27887750
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447025
**Acronym:** Jive
**Brief Title:** An Open Label Extension Study of CTI-1601 in Subjects With Friedreich's Ataxia
**Official Title:** Jive: An Open Label Extension Study to Assess the Long-term Safety, Efficacy, Pharmacodynamics, Pharmacokinetics, and Tolerability of Subcutaneous CTI-1601 in Subjects With Friedreich's Ataxia
#### Organization Study ID Info
**ID:** CLIN-1601-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Larimar Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-25
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-15
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Larimar Therapeutics, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is an open-label extension (OLE) study designed to evaluate the long-term safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of subcutaneous (SC) administration of CTI-1601, also known as nomlabofusp, in subjects with Friedreich's ataxia (FRDA).
The objectives of this OLE study are:
* To evaluate the safety of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA
* To evaluate the PK of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA
* To evaluate the effect of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA on:
* Tissue FXN concentrations
* Clinical evaluations of FRDA
* Gene Expression and select lipids
**Detailed Description:** This is an open label extension (OLE) study in patients with FRDA who participated in a prior clinical study of CTI-1601 to evaluate the safety, PK, PD, and clinical effects of long-term daily administration of CTI-1601.
### Conditions Module
**Conditions:**
- Friedreich Ataxia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CTI-1601 will be administered daily
**Intervention Names:**
- Biological: CTI-1601
**Label:** CTI-1601
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CTI-1601
**Description:** CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
**Name:** CTI-1601
**Other Names:**
- Nomlabofusp
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of subjects with treatment-emergent adverse events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Maximum Severity
**Time Frame:** Up to 24 months
**Measure:** Number of subjects with abnormal laboratory test results
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in electrocardiogram (ECG) parameters including, but not limited to, HR, RR interval, PR interval, QRS duration, QT interval, and QTcF interval
**Time Frame:** Up to 24 months
**Description:** LVEF indicates the percentage of change in LV volume from diastole to systole that measures how well the left ventricle of the heart pumps blood.
**Measure:** Change from baseline in left ventricular ejection fraction (LVEF)
**Time Frame:** Up to 24 months
**Description:** LVEDV is the amount of blood, measured in milliliters (mL), in the heart's left ventricle just before the heart contracts.
**Measure:** Change from baseline in left ventricular end-diastolic volume (LVEDV)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in blood pressure (mmHg)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in pulse (bpm)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in temperature (°C)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in respiration rate (breaths per minute)
**Time Frame:** Up to 24 months
**Description:** The Columbia Suicide Severity Rating Scale (C-SSRS) is a tool used to assess the occurrence, severity, and frequency of suicidal thoughts and behaviors. A higher score on the C-SSRS generally indicate a worse outcome, as they signify a higher level of suicidal ideation or behavior.
**Measure:** Number of subjects with any suicidal ideation or behavior (Categories 1-10) of the Columbia Suicide Severity Rating Scale (C-SSRS)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline at each collection timepoint in tissue frataxin concentrations normalized to total protein observed in buccal cells collected from cheek swabs and skin cells collected from skin punch biopsies
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in motor function as assessed by 9-hole peg test (9-HPT)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in motor function as assessed by the timed 25-foot walk test (T25-FW)
**Time Frame:** Up to 24 months
**Description:** The Modified Friedreich's Ataxia Rating Scale (mFARS) is a modified neurologic scale involving direct subject participation and targets specific areas impacted by Friedreich's ataxia (bulbar, upper limb, lower limb, and upright stability), with scores ranging from 0-67 points, with higher scores indicating a greater level of disability.
**Measure:** Change from baseline in neurologic function as assessed by the modified Friedreich's Ataxia Rating Scale (mFARS) total score
**Time Frame:** Up to 24 months
**Description:** The Upright Stability Subscale is an assessment of an individual's ability to maintain balance and stability while standing upright. It has a minimum value of 0 and a maximum value of 36. A higher score indicates a better outcome, reflecting greater stability and balance abilities while standing upright.
**Measure:** Change from baseline in neurologic function as assessed by the upright stability subscale examination of the mFARS
**Time Frame:** Through study completion, up to 24 months
**Description:** The FARS_ADL, scored 0 to 36, is a subscale of FARS assessing a subject's ability to complete activities of daily living. A higher score indicates a greater level of disability. The FARS_ADL questionnaire will be performed at the timepoints indicated in protocol.
**Measure:** Change in activities of daily living (ADLs) as assessed by the Friedreich's Ataxia Rating Scale Activities of Daily Living (FARS_ADL)
**Time Frame:** Up to 24 months
**Description:** The Modified Fatigue Impact Scale (MFIS) is a revised form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Participants rate on a 5-point scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). The 5-item version is scored (0-20). Higher numbers indicate greater fatigue. The MFIS will be performed at the timepoints indicated in protocol.
**Measure:** Change from baseline in total fatigue score and all the subscale scores as assessed by the Fatigue Impact Scale (MFIS)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in the assessment of disease as assessed by the Functional Staging for Ataxia
**Time Frame:** Up to 24 months
**Description:** The Patient Global Impression of Change (PGI-C) reflects a patient's assessment about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The PGI-C will be performed at the timepoints indicated in protocol.
**Measure:** Overall impression of change as assessed by the patient using the Patient Global Impression of Change (PGI-C) Scale
**Time Frame:** Up to 24 months
**Description:** The Clinical Global Impression of Change (CGI-C) is an assessment to measure change in clinical status (symptoms and functional ability) of the subject's condition from baseline with study drug. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). The CGI-C will be performed at the timepoints indicated in protocol.
**Measure:** Overall impression of change assessed by a clinician using the Clinical Global Impression of Change (CGI-C)
**Time Frame:** Up to 24 months
**Measure:** Area under the concentration-time curve for the dosing interval (AUC0-tau)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Mean maximum observed concentration (Cmax)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Mean time of maximum observed concentration (Tmax)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Concentration reached immediately before the next dose is administered (Ctrough)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with FRDA who previously completed participation in a study of CTI-1601 will be eligible to participate in this study unless the subject experienced one or more of the following in a previous CTI-1601 study: a) serious adverse event (SAE) related to study drug; b) significant AE, defined as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (or higher), related to study drug; c) some other event, related to participation in a previous study with CTI-1601, that supports the exclusion of the subject from participating in this study as determined by the Sponsor (i.e., an AE considered clinically significant by the Sponsor regardless of whether it met SAE criteria and regardless of CTCAE grade); d) Withdraw from participation in a previous study of CTI-1601 for any reason.
* Subject has a HbA1c less than or equal to 7.0%.
* Subject must demonstrate sufficient dexterity and visual acuity to prepare and self-administer SC injections of CTI-1601 QD or is able to identify a caregiver who will be trained and committed to prepare and administer the daily injections.
Exclusion Criteria:
Subjects are excluded from the study if any of the following exclusion criteria are met:
* Subjects who are confirmed as compound heterozygous (GAA repeat expansion on only one allele) for FRDA.
* Subject has any condition, disease, or situation, including a cardiac condition or disease, that in the opinion of the PI, could confound the results of the study or put the subject at undue risk, making participation inadvisable.
* Subject used any investigational drug (other than CTI-1601) or device within 90 days prior to Screening.
* Subject requires use of amiodarone.
* Subject used erythropoietin, etravirine, or gamma interferon within 90 days prior to Screening.
* Subject use of biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days prior to the first dose of study drug. Biotin supplementation ≤30 mcg/day is permitted if taken at a stable dose and frequency for at least 28 days prior to Screening and there is a commitment from the subject to maintain the biotin dose throughout the study (due to interference with assays).
* Subject uses more than 3 grams of acetaminophen daily.
* Subject receives medication that requires SC injection in the abdomen or thigh.
* Subject is unable to discontinue medications that have not been at a stable dose and frequency for at least 28 days prior to Screening.
* Subject has a Screening echocardiogram (ECHO) LVEF \< 45%.
* Male subject has a QTcF \> 450 milliseconds or female subject has a QTcF \> 470 milliseconds on an ECG.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** University of California Los Angeles
**State:** California
**Zip:** 90095
**Location 2:**
**City:** Gainesville
**Country:** United States
**Facility:** Fixel Institute for Neurological Disease, University of Florida Health
**State:** Florida
**Zip:** 32608
**Location 3:**
**City:** Tampa
**Country:** United States
**Facility:** Morsani Center for Advanced Health Care, University of South Florida Health
**State:** Florida
**Zip:** 33612
**Location 4:**
**City:** Iowa City
**Country:** United States
**Facility:** University of Iowa
**State:** Iowa
**Zip:** 52242
**Location 5:**
**City:** Eatontown
**Country:** United States
**Facility:** Clinilabs Drug Development, Corp.
**State:** New Jersey
**Zip:** 07724
**Location 6:**
**City:** Columbus
**Country:** United States
**Facility:** Ohio State University United States
**State:** Ohio
**Zip:** 43210
**Location 7:**
**City:** Philadelphia
**Country:** United States
**Facility:** Hospital of the University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** Larimar Therapeutics, Inc.
**Name:** Larimar Therapeutics, Inc.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Delatycki MB, Corben LA. Clinical features of Friedreich ataxia. J Child Neurol. 2012 Sep;27(9):1133-7. doi: 10.1177/0883073812448230. Epub 2012 Jun 29.
**PMID:** 22752493
**Citation:** Deutsch EC, Santani AB, Perlman SL, Farmer JM, Stolle CA, Marusich MF, Lynch DR. A rapid, noninvasive immunoassay for frataxin: utility in assessment of Friedreich ataxia. Mol Genet Metab. 2010 Oct-Nov;101(2-3):238-45. doi: 10.1016/j.ymgme.2010.07.001. Epub 2010 Jul 8.
**PMID:** 20675166
**Citation:** Fahey MC, Corben L, Collins V, Churchyard AJ, Delatycki MB. How is disease progress in Friedreich's ataxia best measured? A study of four rating scales. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):411-3. doi: 10.1136/jnnp.2006.096008. Epub 2006 Oct 20.
**PMID:** 17056635
**Citation:** Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
**PMID:** 8148458
**Citation:** Goodkin DE, Hertsgaard D, Seminary J. Upper extremity function in multiple sclerosis: improving assessment sensitivity with box-and-block and nine-hole peg tests. Arch Phys Med Rehabil. 1988 Oct;69(10):850-4.
**PMID:** 3178453
**Citation:** Koeppen AH. Friedreich's ataxia: pathology, pathogenesis, and molecular genetics. J Neurol Sci. 2011 Apr 15;303(1-2):1-12. doi: 10.1016/j.jns.2011.01.010.
**PMID:** 21315377
**Citation:** Guidelines MSCfCP. Fatigue and multiple sclerosis: evidence-based management strategies for fatigue in multiple sclerosis. 1998.
**Citation:** Lazaropoulos M, Dong Y, Clark E, Greeley NR, Seyer LA, Brigatti KW, Christie C, Perlman SL, Wilmot GR, Gomez CM, Mathews KD, Yoon G, Zesiewicz T, Hoyle C, Subramony SH, Brocht AF, Farmer JM, Wilson RB, Deutsch EC, Lynch DR. Frataxin levels in peripheral tissue in Friedreich ataxia. Ann Clin Transl Neurol. 2015 Aug;2(8):831-42. doi: 10.1002/acn3.225. Epub 2015 Jul 1.
**PMID:** 26339677
**Citation:** Pandolfo M. Friedreich ataxia. Arch Neurol. 2008 Oct;65(10):1296-303. doi: 10.1001/archneur.65.10.1296.
**PMID:** 18852343
**Citation:** Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Clinical outcomes assessment in multiple sclerosis. Ann Neurol. 1996 Sep;40(3):469-79. doi: 10.1002/ana.410400321.
**PMID:** 8797541
**Citation:** Wang C, Lu N, Chen WC, Li H, Tiwari R, Xu Y, Yue LQ. Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies. J Biopharm Stat. 2020 May 3;30(3):495-507. doi: 10.1080/10543406.2019.1684309. Epub 2019 Nov 10.
**PMID:** 31707908
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000002526
- Term: Cerebellar Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000013132
- Term: Spinocerebellar Degenerations
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000020271
- Term: Heredodegenerative Disorders, Nervous System
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000028361
- Term: Mitochondrial Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4565
- Name: Ataxia
- Relevance: HIGH
- As Found: Ataxia
- ID: M5773
- Name: Cerebellar Ataxia
- Relevance: HIGH
- As Found: Ataxia
- ID: M8741
- Name: Friedreich Ataxia
- Relevance: HIGH
- As Found: Friedreich's Ataxia
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5775
- Name: Cerebellar Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22510
- Name: Spinocerebellar Ataxias
- Relevance: LOW
- As Found: Unknown
- ID: M15929
- Name: Spinocerebellar Degenerations
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22092
- Name: Heredodegenerative Disorders, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M23341
- Name: Mitochondrial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2386
- Name: Friedreich Ataxia
- Relevance: HIGH
- As Found: Friedreich's Ataxia
- ID: T5352
- Name: Spinocerebellar Ataxia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001259
- Term: Ataxia
- ID: D000002524
- Term: Cerebellar Ataxia
- ID: D000005621
- Term: Friedreich Ataxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447012
**Brief Title:** Artificial Intelligence Development for Colorectal Polyp Diagnosis
**Official Title:** Development of a Novel Real Time Computer Assisted Colonoscopy Diagnostic Tool for Colorectal Polyps: Lesion Diagnosis and Personalised Patient Management
#### Organization Study ID Info
**ID:** 323988
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2026-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-04
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** King's College Hospital NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Accurate classification of growths in the large bowel (polyps) identified during colonoscopy is imperative to inform the risk of colorectal cancer. Reliable identification of the cancer risk of individual polyps helps determine the best treatment option for the detected polyp and determine the appropriate interval requirements for future colonoscopy to check the site of removal and for further polyps elsewhere in the bowel.
Current advanced endoscopic imaging techniques require specialist skills and expertise with an associated long learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without Artificial intelligence (AI) is suboptimal. Approximately 25% of bowel polyps that are removed by major surgery are analysed and later proved to be non-cancerous polyps that could have been removed via endoscopy thus avoiding anatomy altering surgery and the associated risks. With accurate polyp diagnosis and risk stratification in real time with AI, such polyps could have been removed non-surgically (endoscopically). Current Computer Assisted Diagnosis (CADx, a form of AI) platforms only differentiate between cancerous and non cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multi-class algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study.
The Investigators aim to develop a novel AI five class pathology prediction risk prediction tool that provides reliable information to identify cancer risk independent of the endoscopists skill.
These 5 categories are chosen because treatment options differ according to the polyp type and future check colonoscopy guidelines require these categories
**Detailed Description:** The use of artificial intelligence in computer-assisted detection (CADe) to detect polyps (pre-cancerous growths) during colonoscopy is gaining increasing interest and acceptance with multiple devices already in the mainstream market. The Investigator know already from work in other countries that detecting more polyps results in a reduced risk of bowel cancer for the patient having the procedure, in the years following their colonoscopy (ie. pre-cancerous growths were detected and removed). This has formed the basis of national bowel cancer screening programmes. With increased detection of colorectal polyps, there is a growing need to correctly identify the nature of the polyp to inform the risk of colorectal cancer with the polyp detected and also the potential future risk to the patient. Accurate polyp diagnosis is also required to determine the correct mode or removal-whether this does require removal at all (leading to conservation of costs and resources in a challenging current climate), whether endoscopic removal is possible and if so by what procedure, whether surgery is required.
Published data demonstrates that approximately one quarter of surgically removed colorectal polyps with patients undergoing major surgery were benign and therefore major surgery could have been avoided with these polyps removed endoscopically reducing the risk of complication and organ preservation for the patient.
Current polyp diagnosis techniques involve the use and interpretation of specialist dyes and magnification endoscopes which come with gaining expertise expertise with an associated learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without AI is suboptimal.
Current polyp diagnosis AI (CADx) algorithms are limited to smaller classification Current CADx platforms differentiate between cancerous and non-cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multiclass algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study
Prospective collection of data:
This study will be conducted alongside usual patient care, but will require research staff to enter data onto a secure web-based report form (REDCAP database). This means that participants will undergo exactly the same procedure, with no differences and no extra visits or data, than would have otherwise have occurred. Participants will be those patients that have been scheduled to have a colonoscopy for the standard reasons. Patients will be invited in the usual way for colonoscopy.
They may - where possible - be sent the PIS with their appointment letter (up to 6 weeks in advance). On arrival in the endoscopy unit, they will be approached by a member of the research team and given a copy of the PIS to read - up to an hour before their procedure. They will be provided face-to-face information and explanation, prior to written consent to allow their data to be collected in the database. As the study does not require any change or additional procedures, The investigator feel that an initial approach on arrival into the endoscopy unit will provide sufficient, appropriate time to consent, even if the PIS has not been read in advance (although it will be sent if possible). The only additional consideration will be the consent to recording of the video (no patient identifiable data will be transferred as part of this aspect).
Once the colonoscopy has been completed, there will be no additional visits.
### Conditions Module
**Conditions:**
- Polyp of Colon
- Colorectal Polyp
**Keywords:**
- Artificial Intelligence
- Computer assisted diagnosis (CADx)
- Colorectal cancer
- Colorectal polyp
- Machine learning
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 4000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** No intervention required from this study, however images will be obtained from patient presenting for colonoscopy
**Name:** Colonoscopy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Sensitivity and Specificity
**Measure:** To achieve an overall accuracy of 85% for the five-classification lesion prediction algorithm.
**Time Frame:** 24 months
**Description:** Assess the accuracy to the trained device
**Measure:** Positive and negative predicted value
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** We will analyse the calculate the histology agreement between the advance endoscopist
**Measure:** Interobserver agreement of the endoscopists' prediction of histology of polyps during the annotation process.
**Time Frame:** 36 months
**Description:** To assess if the prediction of patient gender, ethnicity, and age is possible with use of the developed CADx model.
**Measure:** Sub-analysis of the polyp characteristics focused on different gender and ethnicity.
**Time Frame:** 36 months
**Description:** A qualitative analysis of CADx incorrect diagnoses will also be conducted by a multidisciplinary panel to evaluate potential impact
**Measure:** This will be a sub analysis of an AI algorithm that is trained to predict polyp histology using the prospective data cohort.
**Time Frame:** 36 months
**Description:** We will evaluate if the use of AI during colonoscopy can be a learning tools for endoscopist
**Measure:** Learned effects of AI augmented endoscopy on endoscopist optical diagnosis
**Time Frame:** 36 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- Above 18 years at inclusion Symptomatic or screening colonoscopy
Exclusion Criteria:
* Unable to provide informed consent.
* Colitis Associated Dysplasia
* Polyps at surgical anastomosis sites
* Pregnancy
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All adult (over 18 years) presenting for screening or symptomatic colonoscopy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shraddha B Gulati, MBBS PHD MRCP
**Phone:** +442032996044
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Olaolu Olabintan, MBBS MRCP
**Phone:** +447939056819
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shraddha B Gulati, MBBS PHD MRCP
- **Phone:** +442032996044
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Olaolu Olabintan, MBBS MRCP
- **Phone:** +447939056819
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** King's College Hospital NHS Foundation Trust
**Status:** RECRUITING
**Zip:** SE5 9RS
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000007417
- Term: Intestinal Polyps
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14011
- Name: Polyps
- Relevance: HIGH
- As Found: Polyps
- ID: M6339
- Name: Colonic Polyps
- Relevance: HIGH
- As Found: Polyp of Colon
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M10451
- Name: Intestinal Polyps
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011127
- Term: Polyps
- ID: D000003111
- Term: Colonic Polyps
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446999
**Brief Title:** Yoga-Based Breathing Exercise, Colorectal Cancer Surgery
**Official Title:** The Effect of Yoga-Based Breathing Exercise on Pain, Fatigue, Insomnia, and Self-Efficacy in Individuals Undergoing Colorectal Cancer Surgery-Randomized Controlled Study
#### Organization Study ID Info
**ID:** KaratayFG
#### Organization
**Class:** OTHER
**Full Name:** KTO Karatay University
### Status Module
#### Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** KTO Karatay University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was designed as a prospective, parallel two groups and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery. The sample size of the study was conducted with 60 patients, 30 in the control group and 30 in the experimental group, according to the results of a similar study with the G\*Power 3.1., 9.7 program, with α = 0.05, 80% power and 0.648 effect, and taking into account possible losses. was planned. Research inclusion criteria; Patients who underwent colorectal cancer surgery for the first time were those who were 18 years of age or older, had a mobile phone suitable for downloading the yoga-based breathing exercise video, used the same type and dose of painkillers, and volunteered to participate in the study. "Personal Information Form", "VAS Pain Scale", "Brief Fatigue Inventory", "Richard Campbell Sleep Scale" and "Health Promotion Strategies Used by Patients Scale" will be used to collect data. Participants assigned to the experimental group will be provided with breathing exercises using a protocol containing Yoga-based breathing exercises. In order to conduct the research, approval will be obtained from KTO Karatay University Non-Drug and Medical Device Research Ethics Committee, ethics committee approval and permission will be obtained from the institution where the research will be conducted. Participation in the study is voluntary and written consent will be obtained from the participants. The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical package program. A level of p\<0.05 will be considered statistically significant.
**Detailed Description:** Colorectal cancers are the third most common type of cancer in terms of incidence worldwide and the second leading cause of death. Surgical treatment, chemotherapy and radiotherapy are generally used in the treatment of colorectal cancers. Side effects such as pain, nausea-vomiting, intestinal problems, and fatigue may occur after colorectal cancer surgery (CRCS). In addition, in patients who subsequently receive chemotherapy or radiotherapy, these patients may experience symptom distress and their quality of life may be negatively affected due to side effects such as nausea, vomiting, diarrhea, malnutrition, peripheral neuropathy and fear of cancer recurrence. Pharmacological methods in the management of fatigue are quite limited, and the effect of non-pharmacological approaches such as cognitive behavioral therapies, relaxation, exercise, training of patients and their relatives for fatigue management, exercise, cognitive behavioral therapies, and meditation is effective. Studies evaluating it are increasing. However, it has been stated that very few (10%) of cancer patients experiencing severe fatigue do yoga to manage fatigue. This research was planned to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery.
Type of Research: This study was designed as a prospective, parallel 3-group and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery.
Place and Time of the Research: The research will be conducted at Necmettin Erbakan University Meram Medical Faculty General Surgery Clinic between 01 September 2023 and 30 July 2024.
Population and Sample of the Research: The research population will consist of patients who come for colorectal cancer surgery between 01 September 2023 and 30 July 2024 at Necmettin Erbakan University Meram Faculty of Medicine General Surgery Clinic, where the research will be conducted. The sample number of the study was determined according to the results of a similar study with the G\*Power 3.1., 9.7 program with α = 0.05 and 80% power and 0.648 effect. The sample was determined as 50 patients, 25 patients in the experimental group and 25 patients in the control group. Considering possible losses during the study, it was planned to include a total of 60 patients, 30 patients in the experimental group and 30 patients in the control group.
Data Collection Tools: "Personal Information Form", "VAS Pain Scale", "Brief Fatigue Inventory", "Richard Campbell Sleep Scale" and "Health Promotion Strategies Used by Patients Scale" will be used to collect data.
VAS Pain Scale: It is a scale used to evaluate pain by giving a value between 0 and 10. A score of 0 means no pain, and a score of 10 means unbearable pain. As the score increases, the severity of pain increases.
Brief Fatigue Inventory: The scale evaluates the level of fatigue in the last 24 hours and the reflection of this fatigue on activities in daily life (general activity, mood, walking ability, work life, relationships with other people, joy of life). KYE; It consists of a total of 9 items, 3 items assessing fatigue, general fatigue, and 6 items assessing the impact of fatigue on daily life. Individuals score all items between "0" (no fatigue at all) and "10" (the most severe fatigue you can experience), taking into account the last 24 hours.
Richard Campbell Sleep Scale: The scale developed to determine sleep quality consists of six items: depth of night sleep, time to fall asleep, frequency of waking up, time to fall asleep when woken up, quality of sleep and noise level in the environment. Visual analog scale technique was applied for all expressions. RCUÖ average value; Scale variables are calculated by adding the mean scores and dividing by five. There is only a total score in the scale and the evaluation is made on the average of this score. A total score of the scale between 0 and 25 indicates poor sleep, and a score between 76 and 100 indicates good sleep. An increase in the total score average defines a positive increase in sleep quality.
Health Promotion Strategies Used by Patients Scale: The health promotion strategies used by patients scale was developed. This scale is a 29-item self-report scale. The scale, which initially consisted of 36 items and 4 subscales, was rearranged in 2001. With the factor analysis study called "Confirmatory Factor Analysis", the number of scale items was reduced to 29 and 3 sub-dimensions were defined. These sub-dimensions are: coping with stress, decision making and positive behavior. 1st to 10th of the scale. item, coping with stress sub-dimension, 11th-13th. items decision-making sub-dimension, 14th-29th. The items are the positive behavior subdimension.
Implementation of the Research: Patients who will undergo CRC will be given verbal information about the research before surgery, and those who agree to participate in the research will be evaluated for compliance with the inclusion criteria. The purpose of the research and how it will be implemented will be explained to the patient who meets the criteria for inclusion in the research, and their written consent will be obtained. Initial assessments will be made regarding sociodemographic and health history, VAS Pain score, Fatigue, Insomnia and Self-Efficacy level before surgery/pre-intervention. After the initial evaluation, patients will be assigned according to randomization. For the second evaluation, the VAS Pain score, Fatigue, Insomnia and Self-Efficacy levels of the control and experimental groups will be evaluated on the 4th day after surgery.
Experimental group: A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
Control group: Continuity of routine treatment and care of the patients included in the control group will be ensured. The control group will be recruited before preoperative assignment to patients. After the final test of the patients, information will be given about breathing exercises, and patients who want to do breathing exercises will be provided with a video link uploaded to their mobile phones.
Ethical Dimension of the Research: In order to conduct the research, ethics committee approval was obtained from KTO Karatay University Non-Pharmaceutical and Non-Medical Device Research Ethics Committee and permission was obtained from the institution where the research will be conducted. Participation in the study is voluntary and written consent will be obtained from the participants. To avoid bias, Clinical Trials protocol registration will be made after obtaining permission from the ethics committee.
Statistical Evaluation of Research Data: The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical package program. Descriptive statistics will be given as number of units (n), percentage (%), mean ± standard deviation, median (M), minimum (min) and maximum (max) values. The normal distribution of the data of numerical variables will be evaluated with the Shapiro Wilk normality test. Homogeneity of variances will be evaluated with the Levene test. To evaluate the differences between two independent groups, "Student's t Test" is used when parametric test prerequisites are met; When this could not be achieved, the "Mann Whitney-U test" was used. A level of p\<0.05 will be considered statistically significant.
### Conditions Module
**Conditions:**
- Symptoms and Signs
**Keywords:**
- Colorectal cancer surgery
- Yoga-Based Breathing Exercise
- Pain
- Fatigue
- İnsomnia
- Self Efficacy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1. Experimental group: A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
2. Control group: Continuity of routine treatment and care of the patients included in the control group will be ensured.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The data obtained as a result of the research will be coded as 'A' and 'B' by the researcher and transferred to the computer. In order to prevent bias in the evaluation of the data, the analysis of the coded data will be carried out by an independent statistician, thus ensuring statistician blinding.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
**Intervention Names:**
- Other: Yoga-Based Breathing Exercise
**Label:** Yoga-Based Breathing Exercise
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Continuity of routine treatment and care of the patients included in the control group will be ensured.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Yoga-Based Breathing Exercise
**Description:** Breathing Exercise Protocol Purpose: This protocol is a guide prepared for patients who agree to participate in the study within the scope of scientific research to do breathing exercises.
Materials Required: A comfortable chair/a comfortable bed to lie on and comfortable clothing.
Exercise Duration: Approximately 20 minutes Exercise Time and Frequency: It should be done twice a day, at the same time, in the morning and in the evening.
You can do the exercise before going for a walk in the corridor in the morning and before going to sleep in the evening.
Normal Breathing and Focusing on Breathing (3 minutes) Alternate Nose Breathing-Nadi Shodhana (15-20 times/6 minutes) Normal Breathing and Focusing on Breathing (3 minutes) Bhramari Pranayama-Bee Buzzing Sound(8-10 times/5 minutes) Normal Breathing and Focusing on Breathing (3 minutes)
**Name:** Yoga-Based Breathing Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.
**Measure:** Visual Analog Scale (VAS) - Pain Scale
**Time Frame:** One minute
**Description:** In the evaluation of fatigue, 0 points; no fatigue, 1-3 points; low fatigue, 4-6 points moderate fatigue, 7-9 points; extreme fatigue, 10 points; Fatigue is rated at the highest level.
**Measure:** Brief Fatigue Inventory
**Time Frame:** Two minutes
**Description:** It is a scale consisting of 6 items that assess the depth of nighttime sleep, the time it takes to fall asleep, the frequency of awakenings, the duration of wakefulness upon awakening, the quality of sleep, and the level of noise in the environment. Scores on the scale range from "0-25" indicating very poor sleep to "76-100" indicating very good sleep. While evaluating the total score of the scale based on 5 items, the 6th item, which assesses the level of noise in the environment, is excluded from the total score assessment. As the score on the scale increases, the quality of patients' sleep also increases.
**Measure:** Richard Campbell Sleep Scale
**Time Frame:** Two minutes
**Description:** The minimum score obtained from the scale is 29 and the maximum score is 145. An increase in score indicates that the level of self-efficacy regarding self-care behaviors has increased.
**Measure:** A measure of self-care self-efficacy
**Time Frame:** Two minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Having colo-rectal surgery for the first time
* Have a mobile phone suitable for downloading the yoga-based breathing exercise video,
* Use the same type and dose of painkillers,
* No communication barrier
* Volunteer to participate in the study.
Exclusion Criteria:
* Using sleeping pills,
* Having a physical disability in doing breathing exercises,
* Being diagnosed with a psychiatric disease,
* Having been doing yoga breathing exercises for the last six month
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fatma Gündogdu
**Phone:** 05303243824
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karatay
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Fatma Gündogdu
- **Phone:** 05303243824
- **Role:** CONTACT
**Country:** Turkey
**Facility:** KTO Karatay University
**State:** Konya
**Status:** RECRUITING
**Zip:** 42020
#### Overall Officials
**Official 1:**
**Affiliation:** KTO Karatay University
**Name:** Fatma Gündogdu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** It will be shared when necessary.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ban KA, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, Grant MC, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Colorectal Surgery. Anesth Analg. 2019 May;128(5):879-889. doi: 10.1213/ANE.0000000000003366.
**PMID:** 29649026
**Citation:** Jaya P, Thakur A. Effect of Progressive Muscle Relaxation Therapy on Fatigue and Psychological Distress of Cancer Patients during Radiotherapy: A Randomized Controlled Trial. Indian J Palliat Care. 2020 Oct-Dec;26(4):428-432. doi: 10.4103/IJPC.IJPC_236_19. Epub 2020 Nov 19.
**PMID:** 33623302
**Citation:** Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2.
**PMID:** 34619419
**Citation:** Lev EL, Owen SV. A measure of self-care self-efficacy. Res Nurs Health. 1996 Oct;19(5):421-9. doi: 10.1002/(SICI)1098-240X(199610)19:53.0.CO;2-S.
**PMID:** 8848626
**Citation:** Scheepers ERM, Vink GR, Schiphorst AHW, Emmelot-Vonk MH, van Huis-Tanja LH, Hamakerl ME. Health-related quality-of-life trajectories during/after surgery and adjuvant chemotherapy in patients with colon cancer. Eur Geriatr Med. 2023 Jun;14(3):565-572. doi: 10.1007/s41999-023-00750-9. Epub 2023 Mar 25. Erratum In: Eur Geriatr Med. 2023 May 3;:
**PMID:** 36964869
**Citation:** Schmidt ME, Bergbold S, Hermann S, Steindorf K. Knowledge, perceptions, and management of cancer-related fatigue: the patients' perspective. Support Care Cancer. 2021 Apr;29(4):2063-2071. doi: 10.1007/s00520-020-05686-5. Epub 2020 Aug 29.
**PMID:** 32860177
**Citation:** Yin L, Fan L, Tan R, Yang G, Jiang F, Zhang C, Ma J, Yan Y, Zou Y, Zhang Y, Wang Y, Zhang G. Bowel symptoms and self-care strategies of survivors in the process of restoration after low anterior resection of rectal cancer. BMC Surg. 2018 Jun 4;18(1):35. doi: 10.1186/s12893-018-0368-5.
**PMID:** 29866087
**Citation:** Akin S, Can G, Durna Z, Aydiner A. The quality of life and self-efficacy of Turkish breast cancer patients undergoing chemotherapy. Eur J Oncol Nurs. 2008 Dec;12(5):449-56. doi: 10.1016/j.ejon.2008.07.006. Epub 2008 Oct 7.
**PMID:** 18842460
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
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