Trial Information

Prospective Study of Risk-Reducing Salpingo-Oophorectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants

OBJECTIVES:

- To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast
cancer, primary peritoneal cancer, and all cancer among women at increased risk of
ovarian cancer, with a special emphasis on women who are known BRCA1/2 mutation
carriers.

- To develop precise point estimates of these cancer rates among women who have undergone
risk-reducing salpingo-oophorectomy and women who have elected screening.

- To compare the cancer rates between these two groups of women.

- To better characterize the similarities and differences in cancer risk between BRCA
mutation-positive families and BRCA mutation-negative/family history-positive families.

- To develop preliminary estimates of overall and cancer-specific mortality, stratified
by mutation status (BRCA1-positive, BRCA2-positive, BRCA1/2-negative).

OUTLINE: This is a multicenter study.

Patients complete the Health Update Questionnaire annually for up to 5 years. The
questionnaire focuses specifically on cancer risk, incidence, and mortality. Patients also
receive ongoing communication (e.g., periodic newsletters, copies of study-related
publications, etc.) to keep them informed regarding study-related research results, new
research findings, new research opportunities for which patients may be eligible, and
evolving clinical recommendations regarding hereditary breast/ovarian cancer.