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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer

Intervention / Treatment
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* Procedure: Salpingectomy with delayed oophorectomy
* Procedure: Risk-reducing salpingo-oophorectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salpingectomy with delayed oophorectomy<br>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<br>* 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.<br>* Other names: Tubectomy with delayed oophorectomy;|
| Active Comparator: Risk-reducing salpingo-oophorectomy<br>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<br>* 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.<br>* Other names: Bilateral prophylactic salpingo-oophorectomy;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salpingectomy, Delayed oophorectomy, Salpingo-oophorectomy, Quality of life, Ovarian cancer, BRCA