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

Not Applicable

Active, not recruiting

• Conditions: BRCA2 Gene Mutation; Ovarian Cancer; BRCA1 Gene Mutation
• Interventions: Procedure: Salpingectomy with delayed oophorectomy; Procedure: Risk-reducing salpingo-oophorectomy

• Registration Number: NCT02321228
• Lead Sponsor: University Medical Center Nijmegen

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-22
• Study Start: 2015-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2030-01
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 510

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salpingectomy with delayed oophorectomy	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).
Risk-reducing salpingo-oophorectomy	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

VU University Medical center; 🇳🇱 Amsterdam, Netherlands

Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Medical Center; 🇳🇱 Leeuwarden, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Elisabeth-TweeSteden Hospital; 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Maxima Medical Center; 🇳🇱 Veldhoven, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands