RecruitingRecruiting
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
NCT04294927 · University Medical Center Nijmegen
In plain English
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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.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
* Age at inclusion;
* BRCA1: 25-40 years
* BRCA2: 25-45 years
* RAD51C, RAD51D, BRIP1: 25-50 years
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy
* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
Exclusion Criteria:
* Postmenopausal status (natural menopause or due to treatment)
* Wish for second stage RRO within two years after RRS
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Current diagnosis or treatment for malignant disease
Study design
Enrollment target: 3000 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2020-03-01
Estimated completion: 2040-02-17
Last updated: 2026-04-06
Interventions
Procedure: Risk-reducing salpingectomy with delayed oophorectomyProcedure: Risk-reducing salpingo-oophorectomy
Primary outcomes
- • High grade serous (ovarian) cancer incidence (Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers)
Sponsor
University Medical Center Nijmegen · other
Contacts & investigators
ContactJoanne A. de Hullu, MD, PhD · contact · Joanne.deHullu@radboudumc.nl · +31 (0) 24 36 16683
ContactKaren H. Lu, MD, PhD · contact · khlu@mdanderson.org · (713) 745-8902
InvestigatorJoanne A. de Hullu, MD, PhD · principal_investigator, Radboud University Medical Center
InvestigatorKaren H. Lu, MD, PhD · principal_investigator, M.D. Anderson Cancer Center
InvestigatorRosella P.M.G. Hermens, MD,PhD · principal_investigator, Radboud University Medical Center
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Leuven, Belgium
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Vancouver, Canada
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Nijmegen, Gelderland, Netherlands
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Zwolle, Netherlands
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Stavanger, Norway
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Gdynia, Poland
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Katowice, Poland
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Warsaw, Poland
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Barcelona, Spain
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Montevideo, Uruguay