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
M.D. Anderson Cancer Center
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
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 se…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation. 2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2 3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable 4. Presence of at least one fallopian tube 5. Participants may have a personal history of non-ovarian malignancy…
Interventions
- OtherRIsk-Reducing Salpingectomy (RRS)
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
- OtherRisk-Reducing Oophorectomy-RRO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
- OtherRisk-Reducing Salpingo-Oophorectomy-RRSO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Locations (9)
- Dana Farber Cancer InstituteBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- WU St LouisSt Louis, Missouri
- Mount Sinai Health SystemNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania