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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

NCT05287451 · M.D. Anderson Cancer Center
In plain English

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About this study
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
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 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) 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.
Study design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-05-10
Estimated completion: 2026-12-26
Last updated: 2026-04-15
Interventions
Other: RIsk-Reducing Salpingectomy (RRS)Other: Risk-Reducing Oophorectomy-RROOther: Risk-Reducing Salpingo-Oophorectomy-RRSO
Primary outcomes
  • To evaluate the 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. (through study completion, an average of 15 years)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactRoni Wilke, MD · contact · rnitecki@mdanderson.org · (713) 822-4502
InvestigatorRoni Wilke, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (9)
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
WU St LouisRecruiting
St Louis, Missouri, United States
Mount Sinai Health SystemRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Lyndon Baines Johnson GeneralRecruiting
Houston, Texas, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of WashingtonRecruiting
Seattle, Washington, United States
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 · TrialPath