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: January 9, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Fallopian Tube Cancer

Vaginal Cancer

Treatment

Risk-Reducing Oophorectomy-RRO

RIsk-Reducing Salpingectomy (RRS)

Risk-Reducing Salpingo-Oophorectomy-RRSO

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:

  1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1,RAD51C 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

  3. Childbearing completed or no longer requires fallopian tubes

  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:

  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

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Risk-Reducing Oophorectomy-RRO
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

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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

    Seattle, Washington 98195
    United States

    Active - Recruiting

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