MedTrace Logo

Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers

NCT02321228 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2024-12-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Conditions

Interventions

PROCEDURE

Salpingectomy with delayed oophorectomy

Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.

PROCEDURE

Risk-reducing salpingo-oophorectomy

This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.

Sponsors & Collaborators

  • University Medical Center Nijmegen

    lead OTHER

Principal Investigators

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

  • Rosella PM Hermens, PhD · Scientific Institute for Quality of Healtcare, UMCNijmegen

  • Nicoline Hoogerbrugge, MD, PhD · University Medical Center Nijmegen

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2030-01-31
Completion
2035-01-31

Countries

  • Netherlands

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 NCT02321228 on ClinicalTrials.gov