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A Prospective Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA-125 Screening among Women at Increased Genetic Risk of Ovarian Cancer: Design and Baseline Characteristics: A Gynecologic Oncology Group Study

¹ Clinical Genetics Branch, ² Biostatistics Branch, and ³ Community Oncology and Prevention Trials Research Group, National Cancer Institute, Rockville, Maryland; ⁴ Gynecologic Oncology Group Statistical & Data Center, Roswell Park Cancer Institute, Buffalo, New York; ⁵ Arizona Cancer Center, Tucson, Arizona; ⁶ Memorial Sloan-Kettering Cancer Center, New York, New York; ⁷ Evanston Northwestern Healthcare, Evanston, Illinois; ⁸ St. Elizabeth Medical Center, Edgewood, Kentucky; ⁹ University of North Carolina School of Medicine, Chapel Hill, North Carolina; ¹⁰ Yale University School of Medicine, New Haven, Connecticut; ¹¹ Magee-Women's Hospital of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; and ¹² Tufts-New England Medical Center; ¹³ Massachusetts General Hospital, Boston, Massachusetts

Requests for reprints: Mark H. Greene, Clinical Genetics Branch, National Cancer Institute, 6120 Executive Boulevard, Room EPS 7032, Rockville, MD 20852. Phone: 301-594-7642. E-mail: greenem{at}mail.nih.gov

Background: Women who are genetically predisposed to ovarian cancer are at very high risk of developing this disease. Although risk-reducing salpingo-oophorectomy (RRSO) and various screening regimens are currently recommended to reduce ovarian cancer risk, the optimal management strategy has not been established nor have multiple additional issues been adequately addressed. We developed a collaboration among the Clinical Genetics Branch (National Cancer Institute's Intramural Research Program), the Gynecologic Oncology Group (GOG), and the Cancer Genetics Network to address these issues.

Methods: This is a prospective, international, two-cohort, nonrandomized study of women at genetic risk of ovarian cancer, who chose either to undergo RRSO or screening, at study enrollment. Primary study objectives include quantifying and comparing ovarian and breast cancer incidence in the two study groups, assessing feasibility and selected performance characteristics of a novel ovarian cancer screening strategy (the Risk of Ovarian Cancer Algorithm), evaluating various aspects of quality of life and nononcologic morbidity related to various interventions in at-risk women, and creating a biospecimen repository for subsequent translational research.

Results: Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected. The study design and selected baseline characteristics of cohort members are summarized.

Conclusion: This National Cancer Institute intramural/extramural collaboration will provide invaluable prospectively collected observational data on women at high familial ovarian cancer risk, including substantial numbers of women carrying BRCA1/2 mutations. These data will aid in elucidating the effect of RRSO on breast/ovarian cancer risk and the effects of two management strategies, on quality of life and other issues that may influence patient care, as well as providing preliminary estimates of test specificity and positive predictive value of a novel ovarian cancer screening strategy. (Cancer Epidemiol Biomarkers Prev 2008;17(3):594–604)

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