Recruiting

Salpingectomy with Oophorectomy

Sponsor:

University Medical Center Nijmegen

Code:

NCT04294927

Conditions

BRCA1 Gene Mutation

BRCA2 Gene Mutation

RAD51C Gene Mutation

RAD51D Gene Mutation

BRIP1 Gene Mutation

Eligibility Criteria

Sex: Female

Age: 25 - 50

Healthy Volunteers: Not accepted

Interventions

Risk-reducing salpingectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy

Study Details

Brief summary:

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Conditions

BRCA1 Gene Mutation

BRCA2 Gene Mutation

RAD51C Gene Mutation

RAD51D Gene Mutation

BRIP1 Gene Mutation

Study ID

NCT04294927

Start date

Mar 1, 2020

Status verified date

Oct, 2025

Completion date

Feb 17, 2040

Anticipated

Primary completion date

Feb 17, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
  • Age at inclusion;

  • BRCA1: 25-40 years
  • BRCA2: 25-45 years
  • RAD51C, RAD51D, BRIP1: 25-50 years
  • 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 according to national and local regulatory requirements and the local rules followed in the institution.

Exclusion Criteria:

  • Postmenopausal status (natural menopause or due to treatment)
  • Wish for second stage RRO within two years after RRS
  • Legally incapable
  • Prior bilateral salpingectomy
  • A personal history of ovarian, fallopian tube or peritoneal cancer
  • Current diagnosis or treatment for malignant disease

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Risk-reducing salpingectomy with delayed oophorectomy

Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.

active comparator: Risk-reducing salpingo-oophorectomy

Risk-reducing salpingo-oophorectomy.

Interventions

Risk-reducing salpingectomy with delayed oophorectomy

  • BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45).
  • BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50).
  • BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)

Risk-reducing salpingo-oophorectomy

  • BRCA1 at a maximum age of 40 (advised between age 35 and 40)
  • BRCA2 at a maximum age of 45 (advised between age 40 and 45)
  • BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)

Primary outcome measure

  • High grade serous (ovarian) cancer incidence [ Time Frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers ]

Central Contacts and Locations

Central contacts

Joanne A. de Hullu, MD, PhD

+31 (0) 24 36 16683Joanne.deHullu@radboudumc.nl

Karen H. Lu, MD, PhD

(713) 745-8902khlu@mdanderson.org

Locations

UChicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Washington University Medical Center

Recruiting

St Louis, Missouri, United States, 63110

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Harris Health Lyndon B. Johnson Hospital

Recruiting

Houston, Texas, United States, 77026

MD Anderson Cancer Centre

Recruiting

Houston, Texas, United States, 77030-4009

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Vancouver General Hospital

Recruiting

Vancouver, Canada

More Information

Sponsor

University Medical Center Nijmegen

Last update posted

Apr 6, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Medical Center Nijmegen on 2026-04-06.