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Recruiting NCT04294927

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

Trial Parameters

Condition BRCA1 Gene Mutation
Sponsor University Medical Center Nijmegen
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3,000
Sex FEMALE
Min Age 25 Years
Max Age 50 Years
Start Date 2020-03-01
Completion 2040-02-17
Interventions
Risk-reducing salpingectomy with delayed oophorectomyRisk-reducing salpingo-oophorectomy

Brief Summary

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Eligibility Criteria

Inclusion Criteria: * Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers. * Age at inclusion; * BRCA1: 25-40 years * BRCA2: 25-45 years * RAD51C, RAD51D, BRIP1: 25-50 years * Childbearing completed * Presence of at least one fallopian tube * Participants may have a personal history of non-ovarian malignancy * Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution. Exclusion Criteria: * Postmenopausal status (natural menopause or due to treatment) * Wish for second stage RRO within two years after RRS * Legally incapable * Prior bilateral salpingectomy * A personal history of ovarian, fallopian tube or peritoneal cancer * Current diagnosis or treatment for malignant disease

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