Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
RATIONALE: 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.
PURPOSE: This clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Other: questionnaire administration
Procedure: evaluation of cancer risk factors
Procedure: quality-of-life assessment
Procedure: study of high risk factors
|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|
- Prospective incidence of ovarian cancer (including fallopian tube cancer), primary peritoneal cancer, breast cancer, and all cancer [ Designated as safety issue: No ]
- Ovarian cancer mortality rates [ Designated as safety issue: No ]
- Breast cancer mortality rates [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- 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.