TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention (NCT04294927) | Clinical Trial Compass
RecruitingNot Applicable
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
United States, Australia, Austria3,000 participantsStarted 2020-03-01
Plain-language 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.
Who can participate
Age range
25 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial involves removing the fallopian tubes first and delaying ovary removal, could you walk me through whether that two-step approach might make sense for me given my specific gene mutation — whether it's BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1?
2The trial is measuring whether doing a tubectomy now and keeping my ovaries longer actually reduces my risk of high-grade serous cancer — since this is still being studied, what do we currently know and not know about how safe it is to delay oophorectomy for someone with my mutation?
3Removing the ovaries early causes surgical menopause, which has its own health consequences — is this trial worth discussing as a way to potentially delay that, and how would my age and overall health factor into that conversation?
4If I were to participate in this trial, what would the follow-up monitoring look like, and how long would I need to stay involved before the researchers expect to have meaningful data?
5Would you recommend I consider standard risk-reducing salpingo-oophorectomy now instead of this trial's staged approach, and what would tip the decision one way or the other for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
High grade serous (ovarian) cancer incidence
Timeframe: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers