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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294927
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen

Study Description
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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.

Condition or disease Intervention/treatment Phase
BRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation BRIP1 Gene Mutation Ovarian Cancer Procedure: Risk-reducing salpingectomy with delayed oophorectomy Procedure: Risk-reducing salpingo-oophorectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : February 17, 2040
Estimated Study Completion Date : February 17, 2040

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Peri-operative morbidity and mortality [ Time Frame: 6 weeks after each surgery ]
    Peri-operative morbidity and mortality

  3. Incidence of pelvic cancer (other than ovarian cancer) [ Time Frame: Up to the age of 70 ]
    Incidence of pelvic cancer (other than ovarian cancer)

  4. Incidence of breast cancer [ Time Frame: Up to the age of 70 ]
    Incidence of breast cancer

  5. Uptake of risk reducing oophorectomy [ Time Frame: Up to the age of 70 ]
    Uptake of risk reducing oophorectomy after risk reducing salpingectomy


Other Outcome Measures:
  1. High grade serous (ovarian) cancer incidence at the age of 70 [ Time Frame: Up to the age of 70 ]
    Exploratory outcome measure


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294927


Contacts
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Contact: Joanne A. de Hullu, MD, PhD +31 (0) 24 36 16683 Joanne.deHullu@radboudumc.nl
Contact: Karen H. Lu, MD, PhD (713) 745-8902 khlu@mdanderson.org

Locations
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Netherlands
Elisabeth-TweeSteden Ziekenhuis Recruiting
Tilburg, Brabant, Netherlands
Contact: Caroline Vos, MD         
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Joanne A. de Hullu, MD, PhD    +31 (0) 24 36 16683    Joanne.deHullu@radboudumc.nl   
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Brigitte Slangen, MD, PhD         
Catharina Ziekenhuis Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Jurgen M.J. Piek, MD, PhD       jurgen.piek@catharinaziekenhuis.nl   
Amsterdam University Medical Center Recruiting
Amsterdam, Netherlands
Contact: Luc van Lonkhuijzen, MD, PhD         
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands
Contact: Marc van Beurden, MD, PhD         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: Nathalie Reesink-Peters, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Marian Mourits, MD, PhD         
Medical Center Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Mirjam Apperloo, MD, PhD         
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Katja Gaarenstroom, MD, PhD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Marta Piso-Jozwiak, MD, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Ronald Zweemer, Prof, MD, PhD         
Maxima Medical Center Recruiting
Veldhoven, Netherlands
Contact: Sjors Coppus, MD, PhD         
Isala Klinieken Recruiting
Zwolle, Netherlands
Contact: Arnold-Jan Kruse, MD, PhD         
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
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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
More Information
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Responsible Party: Joanne A. de Hullu, MD, PhD, Dr. J.A. de Hullu, MD, PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT04294927    
Other Study ID Numbers: NL 70691.091.19
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No