TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
NCT ID: NCT04294927
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2020-03-01
2040-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
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)
Risk-reducing salpingo-oophorectomy
Risk-reducing salpingo-oophorectomy.
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
50 Years
FEMALE
No
Sponsors
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University Medical Center Nijmegen
OTHER
Responsible Party
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Joanne A. de Hullu, MD, PhD
Dr. J.A. de Hullu, MD, PhD
Principal Investigators
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Joanne A. de Hullu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Karen H. Lu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Rosella P.M.G. Hermens, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Elizabeth M. Swisher, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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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
Frances Perry House
Melbourne, Victoria, Australia
Mercy Hospital
Melbourne, Victoria, Australia
Epworth Hospital
Richmon, Victoria, Australia
Western Health
St Albans, Victoria, Australia
King Edward Memorial Hospital
Perth, Western Australia, Australia
Monash Health
Melbourne, , Australia
Peter MacCallum Centre
Melbourne, , Australia
Royal Womens Hospital
Melbourne, , Australia
Hopital Universitaire Bruxelles
Brussels, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
AC Camargo Cancer Centre
São Paulo, , Brazil
Universita di Bologna
Bologna, , Italy
San Gerardo Hospital
Monza, , Italy
Gemelli Hospital
Rome, , Italy
Instituto Nacional de Cancerología
Mexico City, , Mexico
Radboudumc
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, Netherlands
Amsterdam University Medical Center
Amsterdam, , Netherlands
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Medical Center Leeuwarden
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Maxima Medical Center
Veldhoven, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Akershus University Hospital
Nordbyhagen, , Norway
Oslo University Hospital
Oslo, , Norway
Stavanger Uniersity Hospital
Stavanger, , Norway
Gdynia Oncology Centre
Gdynia, , Poland
Bonifraterskie Centrum Medyczne
Katowice, , Poland
Medical University of Silesia
Katowice, , Poland
National Cancer Institute Warsaw
Warsaw, , Poland
Karolinksa Institutet
Stockholm, , Sweden
Hospital Británico
Montevideo, , Uruguay
Countries
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Central Contacts
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Facility Contacts
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Karen Lu
Role: primary
Karen Lu
Role: primary
Karen Lu
Role: primary
Elizabeth Swisher
Role: primary
Martha Hickey
Role: primary
Martha Hickey
Role: primary
Martha Hickey
Role: primary
Maxime Fastrez
Role: primary
Susanne Housmans
Role: primary
Glauco Baiocchi
Role: primary
Myriam Perrone
Role: primary
Robert Fruscio
Role: primary
Claudia Marchetti
Role: primary
David Cantu
Role: primary
Brigitte Slangen, MD, PhD
Role: primary
Caroline Vos, MD
Role: primary
Luc van Lonkhuijzen, MD, PhD
Role: primary
Marc van Beurden, MD, PhD
Role: primary
Nathalie Reesink-Peters, MD, PhD
Role: primary
Marian Mourits, MD, PhD
Role: primary
Mirjam Apperloo, MD, PhD
Role: primary
Katja Gaarenstroom, MD, PhD
Role: primary
Marta Piso-Jozwiak, MD, PhD
Role: primary
Ronald Zweemer, Prof, MD, PhD
Role: primary
Sjors Coppus, MD, PhD
Role: primary
Arnold-Jan Kruse, MD, PhD
Role: primary
Anne Dorum
Role: primary
Anne Dorum
Role: primary
Maciej Stukan
Role: primary
Monika Bodjys-Szyndlar
Role: primary
Krzysztof Nowosielski
Role: primary
Agnieszka Rychlik
Role: primary
Angelique Flöter-Radestad
Role: primary
Santiago Scasso
Role: primary
References
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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.
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: 10.1136/ijgc-2023-004377.
Other Identifiers
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NL 70691.091.19
Identifier Type: -
Identifier Source: org_study_id
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