NCT01139957

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,916 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Carcinoma
• Fallopian Tube Carcinoma
• Ovarian Neoplasm
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Evaluation of Cancer Risk Factors	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Study of High Risk Factors	Ancillary studies

Timeline

• Start date: 2010-06-07
• Primary completion: 2020-04-10
• Completion: 2020-04-10
• First posted: 2010-06-09
• Last updated: 2020-09-02

Locations

141 sites across 1 country: United States