NCT02321228

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

Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: University Medical Center Nijmegen · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible women will choose for the innovative or standard risk-reducing option themselves.

Conditions

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2030-01-01
• Completion: 2035-01-01
• First posted: 2014-12-22
• Last updated: 2024-12-05

Locations

13 sites across 1 country: Netherlands