An interventional study of Risk-reducing salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in BRCA1 Gene Mutation, BRCA2 Gene Mutation and RAD51C Gene Mutation, sponsored by University Medical Center Nijmegen. Recruiting at 66 sites in 16 countries. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University Medical Center Nijmegen · Not applicable, Interventional, and Prevention
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.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Age at inclusion;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
Procedure: Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingo-oophorectomy.
Procedure: Risk-reducing salpingo-oophorectomy
* BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45). * BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50). * BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)
* BRCA1 at a maximum age of 40 (advised between age 35 and 40) * BRCA2 at a maximum age of 45 (advised between age 40 and 45) * BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)
High grade serous (ovarian) cancer incidence
High grade serous (ovarian) cancer incidence
Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Incidence of (pre)malignant findings in tubes/ovaries
Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
Time frame: 6 weeks after each surgery
Peri-operative morbidity and mortality
Peri-operative morbidity and mortality
Time frame: 6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Incidence of pelvic cancer (other than ovarian cancer)
Time frame: Up to the age of 70
Incidence of breast cancer
Incidence of breast cancer
Time frame: Up to the age of 70
Uptake of risk reducing oophorectomy
Uptake of risk reducing oophorectomy after risk reducing salpingectomy
Time frame: Up to the age of 70
High grade serous (ovarian) cancer incidence at the age of 70
Exploratory outcome measure
Time frame: Up to the age of 70
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Plan to share: No
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University Medical Center Nijmegen