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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention — TUBA-WISP-II  

Ovarian Cancer Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04294927
Study type Interventional
Source University Medical Center Nijmegen
Contact Joanne A. de Hullu, MD, PhD
Phone +31 (0) 24 36 16683
Email Joanne.deHullu@radboudumc.nl
Status Recruiting
Phase N/A
Start date March 1, 2020
Completion date February 17, 2040
View Details
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