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

University Medical Center Nijmegen13 sites in 1 country510 target enrollmentJanuary 2015

ConditionsBRCA1 Gene Mutation BRCA2 Gene Mutation Ovarian Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: BRCA1 Gene Mutation
Sponsor: University Medical Center Nijmegen
Enrollment: 510
Locations: 13
Primary Endpoint: Menopause-related quality of life
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

January 2035

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University Medical Center Nijmegen

Responsible Party

Principal Investigator

Joanne A. de Hullu, MD, PhD

MD, PhD, gynecologic oncologist, principal clinician

University Medical Center Nijmegen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Menopause-related quality of life

Time Frame: Up to 5 years after last surgery

Measured by the Greene Climacteric Scale

Secondary Outcomes

Surgery-related complications(6 weeks after each surgery)
Cardiovascular risk factors(Up to 5 years after last surgery)
Cost-effectiveness of innovative preventive strategy(10 years after last surgery)
General quality of life(Up to 15 years after last surgery)
Quality of life related items(Up to 15 years after last surgery)
Histopathologic findings of removed fallopian tubes and ovaries(6 weeks after each surgery)
Incidence of cardiovascular diseases(Up to 15 years after last surgery)
Incidence of breast cancer(Up to 15 years after last surgery)
Incidence of ovarian cancer(Up to 15 years after last surgery)