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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
Recruiting
Who can join
Ages 18 and older · Women
Full eligibility criteria
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. * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation. 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. 6. Informed consent must be obtained and documented. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Postmenopausal status (natural menopause or due to (cancer) treatment) * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered. 2. Wish for second stage RRO within two years after RRS (if clear at enrollment) 3. Legally incapable 4. Prior bilateral salpingectomy 5. A personal history of ovarian, fallopian tube, or peritoneal cancer 6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
About the study
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
What is being tested
- RIsk-Reducing Salpingectomy (RRS) (other)
- Risk-Reducing Oophorectomy-RRO (other)
- Risk-Reducing Salpingo-Oophorectomy-RRSO (other)
Sponsor: M.D. Anderson Cancer Center · Participants: 100 · Started: May 10, 2022
Contact the study team
- Roni Wilke, MD · Phone: (713) 822-4502
Official record on ClinicalTrials.gov — NCT05287451
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.