Ovarian Cancer Prevention and Early Detection Study
Name of the TrialProspective Screening Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA-125 Screening in Participants at Increased Genetic Risk of Ovarian Cancer (GOG-0199). See the protocol summary at http://cancer.gov/clinicaltrials/GOG-0199.
Principal InvestigatorDr. Mark H. Greene of NCI's Clinical Genetics Branch, DCEG
Why Is This Trial Important?
Ovarian cancer is the fifth leading cause of cancer death among U.S. women. The lifetime risk of ovarian cancer in the general population is about 1.4 percent by age 70. But, women with mutations in the BRCA1 or BRCA2 genes face cumulative risks of 16-40 percent. For these women, preventive removal of the ovaries and fallopian tubes does lower the risk of ovarian and breast cancer, but the magnitude of these reductions is still uncertain.
Neither the impact of preventive surgery on quality of life, nor the consequences of premature menopause, have been carefully studied in women at high risk. At present, there is no proven screening strategy shown to decrease mortality due to ovarian cancer.
This national trial, conducted with the Gynecologic Oncology Group and the Cancer Genetics Network, will more precisely quantify the extent of cancer risk reduction after preventive surgery, assess both quality of life and incidence of non-cancer diseases related to premature menopause, and evaluate a novel approach to ovarian cancer screening based on quantitative assessment of changes in CA-125 over time.
"About 30 percent of women with ovarian cancer survive longer than five years," said Dr. Greene. "But, if diagnosed and treated before the cancer spreads beyond the ovaries, 90-95 percent of patients live longer than five years. Developing effective prevention and early detection methods is crucial in fighting this disease, particularly for women who are at much greater risk."
Who Can Join This Trial?
The trial seeks to enroll 1,800 women aged 30 or over who are at increased risk of ovarian cancer, either because they or a close relative have a BRCA1 or BRCA2 mutation or because of a strong family history of ovarian and/or breast cancer. See the full list of eligibility criteria at http://cancer.gov/clinicaltrials/GOG-0199.
Where Is This Trial Taking Place?
Multiple study sites are enrolling patients in this trial. See the list of sites at http://cancer.gov/clinicaltrials/GOG-0199.
Who to ContactCall the Gynecologic Oncology Group at 1-800-225-3053 to learn which sites have opened this trial or view the study Web site at http://ovariancancer.GOG199.cancer.gov/.
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