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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2026
  • participants needed
    100
  • sponsor
    M.D. Anderson Cancer Center
Updated on 29 May 2022
BRCA1
BRCA2
fallopian tube

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

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

Details
Condition Ovarian Cancer, Fallopian Tube Cancer
Treatment RIsk-Reducing Salpingectomy (RRS), Risk-Reducing Oophorectomy-RRO, Risk-Reducing Salpingo-Oophorectomy-RRSO
Clinical Study IdentifierNCT05287451
SponsorM.D. Anderson Cancer Center
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation
Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 yearsfor BRIP1, RAD51C, RAD51D
Childbearing completed
Presence of at least one fallopian tube
Participants may have a personal history of non-ovarian malignancy
Informed consent must be obtained and documented

Exclusion Criteria

Postmenopausal status (natural menopause or due to (cancer) treatment)
Wish for second stage RRO within two years after RRS (if clear at enrollment)
Legally incapable
Prior bilateral salpingectomy
A personal history of ovarian, fallopian tube or peritoneal cancer
Current clinical signs, diagnosis or treatment for malignant disease
Clear my responses

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