Radical Fimbriectomy for Young BRCA Mutation Carriers (NCT01608074) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radical Fimbriectomy for Young BRCA Mutation Carriers
France123 participantsStarted 2012-01-09
Plain-language summary
Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
Who can participate
Age range
35 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:
* Woman aged over 35 years
* When project of childbearing is fulfilled
* With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
* Unprepared to undergo bilateral annexectomy
* With or without breast cancer
* Patient affiliated to health insurance
* Dated and signed informed consent
Exclusion Criteria:
* Menopausal woman defined as :
Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH\> 20 UI/l History of hysterectomy and FSH\> 20 UI/l
* Pregnant or breastfeeding woman
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.
1This trial is studying 'radical fimbriectomy' — removal of just the fimbriated end of the fallopian tubes rather than the full tubes and ovaries — as an option for young BRCA1 or BRCA2 mutation carriers. Can you explain whether this more limited surgery might leave me with any residual cancer risk compared to removing the full tubes and ovaries?
2Since this trial is listed as 'active, not recruiting,' does that mean results or safety data might be available soon that could inform my own decision about risk-reducing surgery, and how should I factor that into my timing?
3The trial is measuring the rate of pelvic cancer after fimbriectomy in BRCA mutation carriers. Given that we don't yet have full long-term results, how would you weigh the potential benefit of preserving ovarian function against the uncertainty about whether this surgery adequately reduces my cancer risk?
4Because this is a Phase N/A study — meaning it's more of an observational or feasibility study rather than a randomized controlled trial — what level of confidence can we have in its findings, and should I consider standard risk-reducing salpingo-oophorectomy as a more proven alternative?
5If fimbriectomy turns out not to be sufficient protection based on emerging data from this trial, would I still be able to have a more complete risk-reducing surgery later, and would waiting affect my overall cancer risk given my specific BRCA mutation?
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.