National Ovarian Cancer Prevention and Early Detection Study
Closed to Patient Enrollment, Data Analysis Ongoing
The National Ovarian Cancer and Early Detection Study (GOG-0199) is a prospective study of women who are at increased risk of ovarian cancer, either because they or a close relative have a mutation in the BRCA1 or BRCA2 genes, or because they have a strong family history of breast and/or ovarian cancer. This study is being led by the Clinical Genetics Branch, in close collaboration with the Gynecologic Oncology Group and the Cancer Genetics Network. After discussion with their own health care providers, high-risk women chose either risk-reducing surgery or ovarian cancer screening to manage their ovarian cancer risk. Both groups of women have now been followed for five years to assess the impact of their choice on cancer occurrence and quality of life. The clinical phase of this study is complete, having enrolled 2,605 study participants, and efforts are now focused on addressing the specific endpoints that the study was designed to evaluate.
Ongoing analyses include: (1) the histopathology of risk-reducing salpingo-oophorectomy (RRSO) surgical pathology samples obtained from subjects enrolling in the RRSO arm of this study; (2) performance characteristics of the ROCA screening algorithm in the combined GOG-0199/Cancer Genetics Network screening cohort; (3) baseline quality of life in surgical versus screening arm enrollees; (4) medical decision-making among study participants, assessed at the time of study entry; (5) correlation between ovarian volume and levels of clinically important sex-steroid hormones and the effect of RRSO on serum hormone levels; (6) reproducibility of fallopian tube mucosal atypia histologic diagnosis (a blinded review); (7) prospective risk of breast and serous pelvic cancers in study participants; and (8) natural history of BRCA mutation-negative/strong family history positive breast/ovarian cancer families.
There have been two major publications to date from this project, plus a large number of publications related to our collaboration with the Consortium of Modifiers of BRCA1/2 ("CIMBA"), which aims to discover other genes which influence the likelihood that mutation carriers will develop breast or ovarian cancer.
For more information, contact Mark H. Greene.