Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
Start Date
5/10/2022
Completion Date
12/26/2026
Summary
This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
Detailed Description
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk. PRIMARY OBJECTIVE: To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers. SECONDARY OBJECTIVE: Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy. EXPLORATORY OBJECTIVE: Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
RIsk-Reducing Salpingectomy (RRS)
Risk-Reducing Oophorectomy-RRO
Risk-Reducing Salpingo-Oophorectomy-RRSO
Conditions
Locations
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
WU St Louis
St Louis, Missouri 63130
United States
Mount Sinai Health System
New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Lyndon Baines Johnson General
Houston, Texas 77026
United States
M D Anderson Cancer Center
Houston, Texas 77030
United States
University of Washington
Seattle, Washington 98195
United States