NCT04294927

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

TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: University Medical Center Nijmegen · Academic / Other
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Conditions

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• RAD51C Gene Mutation
• RAD51D Gene Mutation
• BRIP1 Gene Mutation
• Ovarian Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-03-01
• Primary completion: 2040-02-17
• Completion: 2040-02-17
• First posted: 2020-03-04
• Last updated: 2026-04-06

Locations

66 sites across 16 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Germany, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Spain, Sweden, Uruguay