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

Abstract

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, twocohort, 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.

Multianalyte Profiling of Serum Antigens and Autoimmune and Infectious Disease Molecules to Identify Biomarkers Dysregulated in Epithelial Ovarian Cancer

“…Many approaches have been taken to improve the predictive value of CA-125. For example, greater specificity has been reported by serial measurement of CA-125 using a risk of ovarian cancer algorithm but the accuracy is still inadequate for initial diagnosis (11), although it is the subject of an ongoing clinical investigation (12). Although several refinements of the use of CA-125 have been proposed, including the combination of additional markers, a simple and clinically practical ovarian cancer -screening tool remains elusive (13)(14)(15)(16).…”

A screening and prevention programme serving an ethnically diverse population of women at high risk of developing breast and/or ovarian cancer

“…Ethnic and demographic data and an expanded personal and family history (modified from the Gynecologic Oncology Group Protocol 199) are included [14]. Mammography findings and benign breast disease (including number of biopsies and results) and gynaecologic history (age of menarche, age at menopause, age at first and last full-term pregnancies, duration of lactation, use of contraceptives), any hormonal interventions and other past medical history with medications are recorded.…”

Circulating biomarkers in epithelial ovarian cancer diagnosis: from present to future perspective

“…ROCA performance has been successively investigated in several multicenter trials (71)(72)(73)(74)(75). In all these investigations, the reported specificity was 99.8% and the positive predictive value was between 35.1% and 37.5%.…”