Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers (TUBA)

December 4, 2024 updated by: Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen

Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers

The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible women will choose for the innovative or standard risk-reducing option themselves.

Study Type

Interventional

Enrollment (Estimated)

510

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 Locations

  • Netherlands
      • Amsterdam, Netherlands
        • VU University Medical Center
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Leeuwarden, Netherlands
        • Medical Center
      • Nijmegen, Netherlands
        • Radboudumc
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Veldhoven, Netherlands
        • Maxima Medical Center
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Center
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Hospital
      • Tilburg, Noord-Brabant, Netherlands, 5042 AD
        • Elisabeth-TweeSteden Hospital
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
        • Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
        • Erasmus Medical Center

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

21 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
  • Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
  • Childbearing completed
  • Presence of at least one fallopian tube
  • Participants may have a personal history of non-ovarian malignancy

Exclusion Criteria:

  • Postmenopausal status (natural menopause or due to (cancer) treatment)
  • Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
  • Legally incapable
  • Prior bilateral salpingectomy
  • A personal history of ovarian, fallopian tube or peritoneal cancer
  • Evidence of malignant disease at enrollment
  • Treatment for malignant disease at enrollment
  • Inability to read or speak Dutch

BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

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: Salpingectomy with delayed oophorectomy
Female BRCA mutation carriers can opt for early salpingectomy upon completion of childbearing, followed by second stage oophorectomy delayed for five years beyond current guideline ages for risk-reducing salpingo-oophorectomy (i.e. age 40-45 for BRCA1 mutation carriers and 45-50 for BRCA mutation carriers).
Procedure: Salpingectomy with delayed oophorectomy
Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.
Other Names:
  • Tubectomy with delayed oophorectomy
Active Comparator: Risk-reducing salpingo-oophorectomy
Female BRCA mutation carriers can opt for standard risk-reducing salpingo-oophorectomy at current guideline ages (age 35-40 for BRCA1 mutation carriers and age 40-45 for BRCA2 mutation carriers).
Procedure: Risk-reducing salpingo-oophorectomy
This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.
Other Names:
  • Bilateral prophylactic salpingo-oophorectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopause-related quality of life
Time Frame: Up to 5 years after last surgery
Measured by the Greene Climacteric Scale
Up to 5 years after last surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General quality of life
Time Frame: Up to 15 years after last surgery
measured by several questionnaires
Up to 15 years after last surgery
Quality of life related items
Time Frame: Up to 15 years after last surgery
i.e. sexual functioning, cancer worry, satisfaction with decision
Up to 15 years after last surgery
Surgery-related complications
Time Frame: 6 weeks after each surgery
Surgery-related complications
6 weeks after each surgery
Histopathologic findings of removed fallopian tubes and ovaries
Time Frame: 6 weeks after each surgery
- Histopathologic findings of removed fallopian tubes and ovaries
6 weeks after each surgery
Cardiovascular risk factors
Time Frame: Up to 5 years after last surgery
Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases
Up to 5 years after last surgery
Incidence of cardiovascular diseases
Time Frame: Up to 15 years after last surgery
i.e. waist-hip circumference, Fasting blood sample
Up to 15 years after last surgery
Incidence of ovarian cancer
Time Frame: Up to 15 years after last surgery
Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)
Up to 15 years after last surgery
Incidence of breast cancer
Time Frame: Up to 15 years after last surgery
Incidence of breast cancer
Up to 15 years after last surgery
Cost-effectiveness of innovative preventive strategy
Time Frame: 10 years after last surgery
Costs per quality adjusted life year (QALY)
10 years after last surgery

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, University Medical Center Nijmegen
  • Principal Investigator: Rosella PM Hermens, PhD, Scientific Institute for Quality of Healtcare, UMCNijmegen
  • Principal Investigator: Nicoline Hoogerbrugge, MD, PhD, University Medical Center Nijmegen

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)

January 1, 2015

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimated)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50048.091.14

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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