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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

NCT ID: NCT05287451Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-04-15

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

Arms & 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

Outcome measures

Primary

  • 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.

    Time frame: through study completion, an average of 15 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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 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 locations (9)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Colleen Feltmate · Contact
cfeltmate@bwh.harvard.edu
Colleen Feltmate · Principal Investigator

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Jamie N Bakkum-Gamez, MD · Contact
bakkum.jamie@mayo.edu
Jamie N Bakkum-Gamez, MD · Principal Investigator

WU St Louis

St Louis, Missouri, 63130

Recruiting
Andrea Hagemann, MD · Contact
Andrea Hagemann, MD · Principal Investigator

Mount Sinai Health System

New York, New York, 10029

Recruiting
Stephanie Blank, MD · Contact
Stephanie.Blank@mountsinai.org
Stephanie Blank, MD · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Kara Long-Roche, MD · Contact
longrock@mskcc.org
Kara Long-Roche, MD · Principal Investigator

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Sarah Kim, MD · Contact
Sarah.Kim@pennmedicine.upenn.edu
Sarah Kim, MD · Principal Investigator

Lyndon Baines Johnson General

Houston, Texas, 77026

Recruiting
Roni Wilke, MD · Contact
rnitechi@mdanderson.org
Roni Wilke, MD · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Roni Wilke, MD · Contact
713-822-4502rnitecki@mdanderson.org

University of Washington

Seattle, Washington, 98195

Recruiting
Barbara Norquist, MD · Contact
bnorquis@uw.edu
Barbara Norquist, MD · Principal Investigator