The National Ovarian Cancer Prevention and Early Detection Study [CAS 7210]among women at increased genetic risk of ovarian cancer (GOG-199) is the cornerstone of CGBs intervention studies research portfolio. Developed and chaired by Dr. Greene, it is a non-randomized natural history study of risk-reducing salpingo-oophorectomy (RRSO) versusa novel ovarian cancer screening strategy (the ROCA algorithm) [NCI Protocol #02-C-0268]. This study closed to new patient enrollment in November 2006, having accrued 2605 high-risk women (1029 surgery arm;1576 screening arm). Prospective follow-up ends in November 2011. Accomplishments to date include (1) successfully completing subject accrual;(2) completing the research-based BRCA1/2mutation testing for the 1,500 mutation-unknown study participants (including both full sequencing and testing for large deletions, rearrangements);(3) completing the central pathology review of 1037 RRSO samples;(4) publishing a report detailing the rationale and design of the study, along with baseline characteristics of the women in each cohort;(5) developing a preliminary model of the factors which influence the choice of RRSO versusscreening;(6) contributing 1576 screening subjects to a pooled analysis (with the Cancer Genetics Network) of determinants of baseline CA-125 levels (manuscript nearing completion);(7) creating a unique biospecimen repository for future translational research;and (8) negotiating a collaboration between GOG and CIMBA under which DNA and clinical data from our 1400 mutation carriers are being contributed to multiple pooled candidate gene association studies of breast cancer risk, and two genome-wide association studies (GWAS), one for each BRCAgene. One published and 2 submitted manuscripts have resulted from this collaboration, and data from another dozen candidate SNPs are in various stages of analysis and manuscript preparation. Ancillary analyses are now underway related to (1) a detailed description of the characteristics of the eligible analytic study cohort;(2) histopathology findings from baseline RRSO surgical pathology material, emphasizing the fallopian tube mucosa;(3) testing/validation of the medical decision-making model related to choice between surgery and screening;and (4) a description of baseline quality of life by study arm. A collaborative study of the p53 molecular signature, a putative molecular precursor to fallopian tube carcinoma, is in development, and we are implementing plans to extend active follow-up of the entire cohort for an additional 10 years.
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