Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT) (NCT05409222) | Clinical Trial Compass
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Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)
Spain45 participantsStarted 2020-03-12
Plain-language summary
1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT.
2. Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT.
3. Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.
Who can participate
Age range
30 Years – 49 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
. Age between 30 and 49 years
. Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk\> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation.
Exclusion criteria
. Personal history of oophorectomy for benign or malignant ovarian pathology.
. Personal history of breast cancer.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy
Timeframe: 5 years
Trial details
NCT IDNCT05409222
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau