Women at high genetic risk
of ovarian cancer (cancer of the ovaries) were invited to consider
joining this new study, looking at ways to lower the risk of developing
ovarian cancer and to find ovarian cancer earlier. It is being led
by the Clinical Genetics
Branch of the National Cancer Institute, in close collaboration
with the Gynecologic Oncology Group
and the Cancer Genetics
This study closed to new patient enrollment on November 3, 2006,
when it reached its planned accrual goal. Women previously enrolled
in this study remain under prospective follow-up.
This study focuses on women who have mutations in the BRCA1
breast/ovarian cancer susceptibility genes
(either in themselves or in close relatives) or who have a strong
family history of these two cancers. Women with these risk
factors are significantly more likely to develop ovarian
cancer than women without them, often at an earlier-than-usual age
(i.e., before the age of 60).
Other Options for Managing Your Ovarian Cancer Risk
Currently, there are various options for managing the risk of ovarian
cancer in high risk women, including surgical removal of the ovaries
for ovarian cancer, and the use of oral contraceptives (birth control
pills). Surgical removal of the ovaries and fallopian tubes (both
are more likely to develop cancer in carriers of BRCA1 and
BRCA2 gene mutations) is the most widely recommended risk-reducing
option offered to high-risk women. This procedure often, but not
always, protects women from developing ovarian cancer. In addition,
there are data to suggest that removal of the ovaries in premenopausal
high-risk women may also reduce the risk of breast cancer in those
women. As a result, it is widely recommended that surgical removal
of the ovaries and fallopian tubes be seriously considered once
high risk women have completed childbearing.
However, there are a significant number of women for whom surgery
is not an acceptable option when it is initially proposed. For these
high-risk women, current screening recommendations include the use
ultrasound (TVUS) and periodic blood tests to measure the
levels of a chemical in the body called CA-125.
The goals of screening are to detect ovarian cancer at an earlier
point in its development, to reduce the chances of dying from this
disease. However, there is currently no scientific evidence to suggest
that screening for ovarian cancer is effective in achieving these
Evaluating a New Screening Approach
Both the safety and the benefits related to using birth control
pills to reduce the risk of ovarian cancer in high-risk women are
uncertain. Furthermore, there is a pressing need to learn more about
the risks and benefits of removing the ovaries in otherwise healthy
young women. The Ovarian Cancer Prevention and Early Detection Study
will help us to gather more information on these questions, while
evaluating a new approach to ovarian cancer screening.
GOG-0199 Study Has Completed Prospective Follow-up
GOG-0199 was designed to follow each woman who enrolled in the study for 5 years after enrollment. This permitted our research team to monitor the events which occurred after study participants selected either surgery (risk-reducing salpingo-oophorectomy) or ovarian cancer screening as their preferred means of managing their ovarian cancer risk. This 5-year follow-up period ended in November 2011. The cancer screening and active follow-up are no longer being conducted. Study investigators are now devoting their time and energy to analyzing the large amounts of data that were collected while the study was ongoing, and then publishing these results in the scientific literature, to share what we have learned with both health care providers and to women at increased risk of ovarian and breast cancer. Therefore, new patients are no longer being enrolled.
Consented study participants who are interested in receiving periodic updates on the outcomes of this research should look for more information in the mail or contact the Research Nurse at the GOG site where you enrolled.