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

Last updated: November 3, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Ovarian Cysts

Fallopian Tube Cancer

Treatment

RIsk-Reducing Salpingectomy (RRS)

Risk-Reducing Salpingo-Oophorectomy-RRSO

Risk-Reducing Oophorectomy-RRO

Clinical Study ID

NCT05287451
2021-1089
NCI-2022-01291
  • Ages > 18
  • Female

Study 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

Eligibility Criteria

Inclusion

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 yearsfor BRIP1, RAD51C, RAD51D, and PALB2

  3. No longer requires fallopian tubes for natural childbearing. Future plans for IVFare 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

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. AromataseInhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) areallowed.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: RIsk-Reducing Salpingectomy (RRS)
Phase:
Study Start date:
May 10, 2022
Estimated Completion Date:
December 26, 2026

Study 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

Connect with a study center

  • Harvard Cancer Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • WU St Louis

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Mount Sinai Health System

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Lyndon Baines Johnson General

    Houston 4699066, Texas 4736286 77026
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98195
    United States

    Active - Recruiting

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