TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- BRIP1 Gene Mutation
- Ovarian Cancer
- RAD51C Gene Mutation
- RAD51D Gene Mutation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 25 years and 50 years
- Gender
- Only males
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, th...
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.
Tracking Information
- NCT #
- NCT04294927
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joanne A. de Hullu, MD, PhD Radboud University Principal Investigator: Karen H. Lu, MD, PhD M.D. Anderson Cancer Center Principal Investigator: Rosella P.M.G. Hermens, MD,PhD Radboud University Principal Investigator: Elizabeth M. Swisher, MD, PhD University of Washington
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