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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.
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.
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.
Age
25 - 50 years
Sex
FEMALE
Healthy Volunteers
No
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
MD Anderson Cancer Centre
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Westmead hospital
Sydney, New South Wales, Australia
St Andrew War Memorial Hospital
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Brisbane, Queensland, Australia
Greenslopes Private Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Start Date
March 1, 2020
Primary Completion Date
February 17, 2040
Completion Date
February 17, 2040
Last Updated
October 20, 2025
3,000
ESTIMATED participants
Risk-reducing salpingectomy with delayed oophorectomy
PROCEDURE
Risk-reducing salpingo-oophorectomy
PROCEDURE
Lead Sponsor
University Medical Center Nijmegen
NCT03428802
NCT04585074
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