A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced … (NCT04251052) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
United States, Canada, South Korea1,956 participantsStarted 2020-09-01
Plain-language summary
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
Who can participate
Age range
35 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:
* Individuals 35-50 years of age, inclusive
* Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
* At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
* Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
* Patients may be premenopausal or menopausal
* Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI and CA-125 within 180 days of registration
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingec…
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 comparing two surgical procedures for people with BRCA1 mutations to reduce the risk of ovarian cancer — one of those options is likely a salpingectomy now followed by oophorectomy later, rather than removing everything at once. Can you explain both surgical approaches being studied and how each one might affect my long-term cancer risk and hormonal health?
2Since this trial is listed as 'Phase NA,' it seems to be a surgical comparison study rather than a drug trial — what does that mean for how much is already known about the safety and effectiveness of these two procedures, and are there established guidelines I should be aware of before considering enrollment?
3The main thing this study is measuring is how long it takes for high-grade serous carcinomas to develop — which means participants will be monitored over time without certainty about which approach is more protective. How comfortable should I be with that uncertainty given my specific BRCA1 mutation status and family history?
4If I delay a full oophorectomy as part of one of these surgical options, what does that mean for my exposure to natural hormones in the meantime, and are there risks to my heart health or bone density that I should weigh against the potential cancer risk reduction?
5Would you recommend I consider standard risk-reducing surgery outside of this trial first, or do you think enrolling in this study is actually the better path for someone in my situation, given that it's still actively recruiting and the long-term outcome data won't be available for years?
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
Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers