Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis (NCT03806426) | Clinical Trial Compass
UnknownPhase 3
Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis
Italy204 participantsStarted 2018-12-05
Plain-language summary
2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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
. Must give written informed consent.
. Male or female subjects, 18 to 65 years of age.
. Known diagnosis of FAP defined as those with a pathogenic APC mutation
. Patients have had a previous colectomy with an ileo-rectal anastomosis or an ileal pouch- anal anastomosis with a rectal remnant of ≥ 2cm.
. Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS).
. Subjects must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the trial. A cardio protective dose of aspirin (75mg-100mg) will be permitted.
Exclusion criteria
. Subjects with ileo-rectal anastomosis who have ≥ 20 polyps which are of \>5mm that are not amendable to removal in the rectum.
. Subjects unwilling to have regular sigmoidoscopy examination.
. Subjects who are due to undergo gastro-intestinal surgery related to FAP.
. History of invasive carcinoma in the past 3 years.
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
Total Number of Polypectomies (polyps > 5mm in the rectum) conducted during the 24 months study period