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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2025

Detailed Description

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

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • General quality of life
    • Time Frame: Up to 15 years after last surgery
    • measured by several questionnaires
  • Quality of life related items
    • Time Frame: Up to 15 years after last surgery
    • i.e. sexual functioning, cancer worry, satisfaction with decision
  • Surgery-related complications
    • Time Frame: 6 weeks after each surgery
    • Surgery-related complications
  • Histopathologic findings of removed fallopian tubes and ovaries
    • Time Frame: 6 weeks after each surgery
    • – Histopathologic findings of removed fallopian tubes and ovaries
  • 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
  • Incidence of cardiovascular diseases
    • Time Frame: Up to 15 years after last surgery
    • i.e. waist-hip circumference, Fasting blood sample
  • 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)
  • Incidence of breast cancer
    • Time Frame: Up to 15 years after last surgery
    • Incidence of breast cancer
  • Cost-effectiveness of innovative preventive strategy
    • Time Frame: 10 years after last surgery
    • Costs per quality adjusted life year (QALY)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Nijmegen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joanne A. de Hullu, MD, PhD, MD, PhD, gynecologic oncologist, principal clinician – University Medical Center Nijmegen
  • Overall Official(s)
    • Joanne A de Hullu, MD, PhD, Principal Investigator, University Medical Center Nijmegen
    • Rosella PM Hermens, PhD, Principal Investigator, Scientific Institute for Quality of Healtcare, UMCNijmegen
    • Nicoline Hoogerbrugge, MD, PhD, Principal Investigator, University Medical Center Nijmegen

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