TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention (TUBA-WISP-II)

March 31, 2026 updated by: Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Brisbane, Australia
      • Melbourne, Australia
        • Recruiting
        • Monash Health
        • Contact:
          • Martha Hickey
      • Melbourne, Australia
        • Recruiting
        • Peter MacCallum Centre
        • Contact:
          • Martha Hickey
      • Melbourne, Australia
        • Recruiting
        • Royal Womens Hospital
        • Contact:
          • Martha Hickey
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
      • Sydney, New South Wales, Australia, 2050
    • Queensland
      • Brisbane, Queensland, Australia, 4001
      • Brisbane, Queensland, Australia, 4006
      • Brisbane, Queensland, Australia, 4120
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Melbourne, Victoria, Australia, 3050
      • Melbourne, Victoria, Australia, 3084
      • Richmon, Victoria, Australia, 3121
      • St Albans, Victoria, Australia, 3021
    • Western Australia
      • Perth, Western Australia, Australia, 6008
  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University of Graz
        • Contact:
          • Karl Tamussino
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Hopital Universitaire Bruxelles
        • Contact:
          • Maxime Fastrez
      • Leuven, Belgium
        • Recruiting
        • Universitair Ziekenhuis Leuven
        • Contact:
          • Susanne Housmans
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • AC Camargo Cancer Centre
        • Contact:
          • Glauco Baiocchi
  • Canada
      • Vancouver, Canada
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Janice Kwon
  • Germany
      • Amberg, Germany
        • Not yet recruiting
        • Klinikum St. Marien Amberg
        • Contact:
          • Thomas Papathemelis
      • Berlin-Spandau, Germany
        • Recruiting
        • Evangelische Waldkrankenhaus Spandau Berlin
        • Contact:
          • Katharina Carrizo
      • Detmold, Germany
        • Not yet recruiting
        • Klinikum Lippe Detmold
        • Contact:
          • Beyhan Ataseven
      • Essen, Germany
        • Recruiting
        • Evang. Kliniken Essen-Mitte
        • Contact:
          • Philipp Harter
  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Zibi Marchoki
  • Italy
      • Bologna, Italy
        • Recruiting
        • Universita di Bologna
        • Contact:
          • Myriam Perrone
      • Milan, Italy
        • Recruiting
        • Humanitas San Pio X
        • Contact:
          • Fabio Martinelli
      • Monza, Italy
        • Recruiting
        • San Gerardo Hospital
        • Contact:
          • Robert Fruscio
      • Rome, Italy
        • Recruiting
        • Gemelli Hospital
        • Contact:
          • Claudia Marchetti
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
          • David Cantu
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Antoni van Leeuwenhoek
        • Contact:
          • Teska Schuurman, MD, PhD
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam University Medical Center
        • Contact:
          • Luc van Lonkhuijzen, MD, PhD
      • Breda, Netherlands
        • Recruiting
        • Amphia
        • Contact:
          • Janneke Hoogstad, MD, PhD
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:
          • Nathalie Reesink-Peters, MD, PhD
      • Groningen, Netherlands
        • Recruiting
        • University Medical Center Groningen
        • Contact:
          • Marise Wagener, MD, PhD
      • Leeuwarden, Netherlands
        • Recruiting
        • Medical Center Leeuwarden
        • Contact:
          • Mirjam Apperloo, MD, PhD
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Medical Center
        • Contact:
          • Katja Gaarenstroom, MD, PhD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Contact:
          • Eva Roes, MD, PhD
      • Utrecht, Netherlands
        • Recruiting
        • University Medical Center Utrecht
        • Contact:
          • Ronald Zweemer, Prof, MD, PhD
      • Veldhoven, Netherlands
        • Recruiting
        • Maxima Medical Center
        • Contact:
          • Sjors Coppus, MD, PhD
      • Zwolle, Netherlands
        • Recruiting
        • Isala Klinieken
        • Contact:
          • Arnold-Jan Kruse, MD, PhD
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
          • Brigitte Slangen, MD, PhD
    • North Brabant
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Tilburg, North Brabant, Netherlands
        • Recruiting
        • Elisabeth-TweeSteden Ziekenhuis
        • Contact:
          • Caroline Vos, MD
  • Norway
      • Nordbyhagen, Norway
        • Active, not recruiting
        • Akershus University Hospital
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Anne Dorum
      • Stavanger, Norway
        • Recruiting
        • Stavanger Uniersity Hospital
        • Contact:
          • Anne Dorum
  • Poland
      • Gdynia, Poland
        • Recruiting
        • Gdynia Oncology Centre
        • Contact:
          • Maciej Stukan
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia
        • Contact:
          • Krzysztof Nowosielski
      • Katowice, Poland
        • Recruiting
        • Bonifraterskie Centrum Medyczne
        • Contact:
          • Monika Bodjys-Szyndlar
      • Warsaw, Poland
        • Recruiting
        • National Cancer Institute Warsaw
        • Contact:
          • Agnieszka Rychlik
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall D'Hebron Barcelona
        • Contact:
          • Judith Balmana
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinksa Institutet
        • Contact:
          • Angelique Flöter-Radestad
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • UChicago Medicine
        • Contact:
          • Kathryn Mills
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Karen Lu
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Karen Lu
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Medical Center
        • Contact:
          • Andrea Hagemann
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Kara Long Roche
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Stephanie Blank
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Hospital
        • Contact:
          • Haley Moss
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Sarah Kim
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Recruiting
        • Md Anderson Cancer Centre
        • Contact:
          • Karen Lu
      • Houston, Texas, United States, 77026
        • Recruiting
        • Harris Health Lyndon B. Johnson Hospital
        • Contact:
          • Michaela Onstad-Grinsfelder
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Elizabeth Swisher
  • Uruguay
      • Montevideo, Uruguay
        • Recruiting
        • Hospital Britanico
        • Contact:
          • Santiago Scasso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
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)
Active Comparator: Risk-reducing salpingo-oophorectomy
Risk-reducing salpingo-oophorectomy.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High grade serous (ovarian) cancer incidence
Time Frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
High grade serous (ovarian) cancer incidence
Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of (pre)malignant findings in tubes/ovaries
Time Frame: 6 weeks after each surgery
Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
6 weeks after each surgery
Peri-operative morbidity and mortality
Time Frame: 6 weeks after each surgery
Peri-operative morbidity and mortality
6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Time Frame: Up to the age of 70
Incidence of pelvic cancer (other than ovarian cancer)
Up to the age of 70
Incidence of breast cancer
Time Frame: Up to the age of 70
Incidence of breast cancer
Up to the age of 70
Uptake of risk reducing oophorectomy
Time Frame: Up to the age of 70
Uptake of risk reducing oophorectomy after risk reducing salpingectomy
Up to the age of 70

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
High grade serous (ovarian) cancer incidence at the age of 70
Time Frame: Up to the age of 70
Exploratory outcome measure
Up to the age of 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Nijmegen

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

February 17, 2040

Study Completion (Estimated)

February 17, 2040

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 70691.091.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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