Status:
RECRUITING
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
Lead Sponsor:
University Medical Center Nijmegen
Conditions:
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Eligibility:
FEMALE
25-50 years
Phase:
NA
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 can...
Detailed Description
In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 17 2040
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04294927
Start Date
March 1 2020
End Date
February 17 2040
Last Update
October 20 2025
Active Locations (48)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
MD Anderson Cancer Centre
Houston, Texas, United States, 77030-4009
4
University of Washington
Seattle, Washington, United States, 98195