TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risk-reducing salpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy.
- Who it may be relevant to
- Registry conditions: BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation. Basic parameters: 25 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belgium, Brazil +11
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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)
Primary outcome measures
- High grade serous (ovarian) cancer incidence [Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers]
Secondary outcome measures (5)
- Incidence of (pre)malignant findings in tubes/ovaries [Time frame: 6 weeks after each surgery]
- Peri-operative morbidity and mortality [Time frame: 6 weeks after each surgery]
- Incidence of pelvic cancer (other than ovarian cancer) [Time frame: Up to the age of 70]
- Incidence of breast cancer [Time frame: Up to the age of 70]
- Uptake of risk reducing oophorectomy [Time frame: Up to the age of 70]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Australia · 15 centers
- Chris O'Brien Lifehouse — Sydney
- Westmead hospital — Sydney
- St Andrew War Memorial Hospital — Brisbane
- Royal Brisbane Hospital — Brisbane
- Greenslopes Private Hospital — Brisbane
- Royal Adelaide Hospital — Adelaide
- Frances Perry House — Melbourne
- Mercy Hospital — Melbourne
- … and 7 more centers
Netherlands · 15 centers
- Radboudumc — Nijmegen
- Maastricht University Medical Center — Maastricht
- Catharina Ziekenhuis — Eindhoven
- Elisabeth-TweeSteden Ziekenhuis — Tilburg
- Amsterdam University Medical Center — Amsterdam
- Antoni van Leeuwenhoek — Amsterdam
- Amphia — Breda
- Medisch Spectrum Twente — Enschede
- … and 7 more centers
United States · 11 centers
- UChicago Medicine — Chicago
- Dana Farber Cancer Institute — Boston
- Mayo Clinic — Rochester
- Washington University Medical Center — St Louis
- Mount Sinai Hospital — New York
- Memorial Sloan Kettering Cancer Center — New York
- Duke University Hospital — Durham
- Hospital of the University of Pennsylvania — Philadelphia
- … and 3 more centers
Germany · 4 centers
- Klinikum St. Marien Amberg — Amberg
- Evangelische Waldkrankenhaus Spandau Berlin — Berlin-Spandau
- Klinikum Lippe Detmold — Detmold
- Evang. Kliniken Essen-Mitte — Essen
Italy · 4 centers
- Universita di Bologna — Bologna
- Humanitas San Pio X — Milan
- San Gerardo Hospital — Monza
- Gemelli Hospital — Rome
Poland · 4 centers
- Gdynia Oncology Centre — Gdynia
- Bonifraterskie Centrum Medyczne — Katowice
- Medical University of Silesia — Katowice
- National Cancer Institute Warsaw — Warsaw
Norway · 3 centers
- Akershus University Hospital — Nordbyhagen
- Oslo University Hospital — Oslo
- Stavanger Uniersity Hospital — Stavanger
Belgium · 2 centers
- Hopital Universitaire Bruxelles — Brussels
- Universitair Ziekenhuis Leuven — Leuven
Austria · 1 center
- Medical University of Graz — Graz
Brazil · 1 center
- AC Camargo Cancer Centre — São Paulo
Canada · 1 center
- Vancouver General Hospital — Vancouver
Ireland · 1 center
- Cork University Hospital — Cork
Mexico · 1 center
- Instituto Nacional de Cancerología — Mexico City
Spain · 1 center
- Vall D'Hebron Barcelona — Barcelona
Sweden · 1 center
- Karolinksa Institutet — Stockholm
Uruguay · 1 center
- Hospital Británico — Montevideo
Publications
- Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7. PMID 39509704
- Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: PMID 37045546
Identifiers
NCT: NCT04294927 · NL 70691.091.19