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

  • End date
    Feb 17, 2040
  • participants needed
  • sponsor
    University Medical Center Nijmegen
Updated on 9 October 2021
ovarian cancer
fallopian tube
cancer of the ovary


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.


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 population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Condition ovarian tumors, Ovarian disorder, RAD51D Gene Mutation, cancer, ovarian, RAD51C Gene Mutation, Recurrent Ovarian Cancer, cancer ovarian, Ovarian Function, BRCA1 Gene Mutation, cancer of the ovary, BRCA2 Mutation, Ovarian Cancer, ovarian carcinomas, BRCA2 Gene Mutation, BRIP1 Gene Mutation
Treatment Risk-reducing salpingo-oophorectomy, Risk-reducing salpingectomy with delayed oophorectomy
Clinical Study IdentifierNCT04294927
SponsorUniversity Medical Center Nijmegen
Last Modified on9 October 2021


Yes No Not Sure

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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