TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
TUBA-WISP-II
1 other identifier
interventional
3,000
11 countries
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 17, 2040
October 20, 2025
October 1, 2025
20 years
March 1, 2020
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
High grade serous (ovarian) cancer incidence
High grade serous (ovarian) cancer incidence
Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Secondary Outcomes (5)
Incidence of (pre)malignant findings in tubes/ovaries
6 weeks after each surgery
Peri-operative morbidity and mortality
6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Up to the age of 70
Incidence of breast cancer
Up to the age of 70
Uptake of risk reducing oophorectomy
Up to the age of 70
Other Outcomes (1)
High grade serous (ovarian) cancer incidence at the age of 70
Up to the age of 70
Study Arms (2)
Risk-reducing salpingectomy with delayed oophorectomy
EXPERIMENTALRisk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
Risk-reducing salpingo-oophorectomy
ACTIVE COMPARATORRisk-reducing salpingo-oophorectomy.
Interventions
* 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)
* 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
You may qualify if:
- Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
MD Anderson Cancer Centre
Houston, Texas, 77030-4009, United States
University of Washington
Seattle, Washington, 98195, United States
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050, Australia
Westmead hospital
Sydney, New South Wales, 2145, Australia
St Andrew War Memorial Hospital
Brisbane, Queensland, 4001, Australia
Royal Brisbane Hospital
Brisbane, Queensland, 4006, Australia
Greenslopes Private Hospital
Brisbane, Queensland, 4120, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Frances Perry House
Melbourne, Victoria, 3050, Australia
Mercy Hospital
Melbourne, Victoria, 3084, Australia
Epworth Hospital
Richmon, Victoria, 3121, Australia
Western Health
St Albans, Victoria, 3021, Australia
King Edward Memorial Hospital
Perth, Western Australia, 6008, 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, 5623 EJ, 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
Related Publications (2)
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: 39509704DERIVEDSteenbeek 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.
PMID: 37045546DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne A. de Hullu, MD, PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Karen H. Lu, MD, PhD
M.D. Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Rosella P.M.G. Hermens, MD,PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Elizabeth M. Swisher, MD, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. J.A. de Hullu, MD, PhD
Study Record Dates
First Submitted
March 1, 2020
First Posted
March 4, 2020
Study Start
March 1, 2020
Primary Completion (Estimated)
February 17, 2040
Study Completion (Estimated)
February 17, 2040
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share