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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

NCT04294927 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-04-06

No results posted yet for this study

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
  • Ovarian Cancer

Interventions

PROCEDURE

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)

PROCEDURE

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)

Sponsors & Collaborators

  • University Medical Center Nijmegen

    lead OTHER

Principal Investigators

  • Joanne A. de Hullu, MD, PhD · Radboud University Medical Center

  • Karen H. Lu, MD, PhD · M.D. Anderson Cancer Center

  • Rosella P.M.G. Hermens, MD,PhD · Radboud University Medical Center

  • Elizabeth M. Swisher, MD, PhD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2040-02-17
Completion
2040-02-17

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Germany
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Uruguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294927 on ClinicalTrials.gov