Clinical Trials

Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer

Location:

Trial status:

Inactive

Why is this study being done?

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.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Enrolled on GOG-0199

- Completed the original 5-year follow-up period OR is off-study due to pregnancy or development of a new cancer

- Completed the Off-Study form (Form Q0-0199 submitted via SEDES)

- No patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Last updated: 07/18/2012

NCT ID: NCT01139957

IRB Number:10-004364