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

ConditionsBRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation BRIP1 Gene Mutation Ovarian Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age25-50

SponsorUniversity Medical Center Nijmegen

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Postmenopausal status (natural menopause or due to treatment)

Wish for second stage RRO within two years after RRS

Legally incapable

Prior bilateral salpingectomy

Trial design

Treatments tested in this trial

Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingo-oophorectomy

Treatment groups

3,000 Participants

are divided into 2 treatment groups

Locations

Australia

Chris O'Brien Lifehouse2050, SydneyNew South Wales, Australia

Westmead hospital2145, SydneyNew South Wales, Australia

Greenslopes Private Hospital4120, BrisbaneQueensland, Australia

Royal Brisbane Hospital4006, BrisbaneQueensland, Australia

Sponsors and collaborators

University Medical Center Nijmegen

Lead sponsor

Source ClinicalTrials.gov