Breast Carcinoma Clinical Trial
Official title:
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
This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. Gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.
PRIMARY OBJECTIVES:
I. 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 breast cancer susceptibility gene
(BRCA)1/2 mutation carriers.
II. To develop precise point estimates of these cancer rates among women who have undergone
risk-reducing salpingo-oophorectomy and women who have elected screening.
III. To compare the cancer rates between these two groups of women. IV. To better
characterize the similarities and differences in cancer risk between BRCA mutation-positive
families and BRCA mutation-negative/family history-positive families.
V. 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.
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