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

N/AActive Not RecruitingNCT02321228

University Medical Center Nijmegen510 enrolled

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

510

Conditions

BRCA1 Gene Mutation BRCA2 Gene Mutation Ovarian Cancer

Interventions

Salpingectomy with delayed oophorectomyPROCEDURE

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.

Risk-reducing salpingo-oophorectomyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (13)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, Netherlands

Outcomes

Primary Outcomes

Menopause-related quality of life

Measured by the Greene Climacteric Scale

Time frame: Up to 5 years after last surgery

Secondary Outcomes

General quality of life

measured by several questionnaires

Time frame: Up to 15 years after last surgery

Quality of life related items

i.e. sexual functioning, cancer worry, satisfaction with decision

Time frame: Up to 15 years after last surgery

Surgery-related complications

Time frame: 6 weeks after each surgery

Histopathologic findings of removed fallopian tubes and ovaries

\- Histopathologic findings of removed fallopian tubes and ovaries

Time frame: 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

Time frame: Up to 5 years after last surgery

Incidence of cardiovascular diseases

i.e. waist-hip circumference, Fasting blood sample

Time frame: Up to 15 years after last surgery

Incidence of ovarian cancer

Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)

Time frame: Up to 15 years after last surgery

Data from ClinicalTrials.gov

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