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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Università 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 Británico
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Nijmegen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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