Women at high genetic [glossary term:] 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 Network. 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 [glossary term:] BRCA1 and [glossary term:] BRCA2 breast/ovarian cancer susceptibility [glossary term:] genes (either in themselves or in close relatives) or who have a strong family history of these two cancers. Women with these [glossary term:] 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 [glossary term:] ovaries and [glossary term:] fallopian tubes, [glossary term:] screening 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 of [glossary term:] transvaginal ultrasound (TVUS) and periodic blood tests to measure the levels of a chemical in the body called [glossary term:] 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 goals.

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

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.