A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Poly… (NCT04678011) | Clinical Trial Compass
RecruitingNot Applicable
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
United States, Netherlands1,000 participantsStarted 2021-11-24
Plain-language summary
The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.
Who can participate
Age range
18 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:
* Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (\>100 colorectal adenomas in combination with a positive family history of FAP)
* Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
* Age 18 years or older
Exclusion Criteria:
* Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
* Cancer at baseline endoscopy
* Need for surgery
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 is focused on surveillance and intervention after a colectomy or proctocolectomy, would I need to have already had that surgery to be considered for enrollment, and how does my current surgical history fit?
2This trial is measuring 'advanced neoplasia' as its primary outcome — can you explain what that means in the context of FAP after colectomy, and what signs or findings they would be watching for in me specifically?
3Because this is a personalized surveillance protocol, what does that actually involve in terms of visits, procedures like endoscopies, or lifestyle changes, and how demanding would that be to fit into my regular life?
4Since this trial is listed as 'Phase NA,' meaning it's more of a protocol or observational study than a traditional drug trial, how does that affect what's known about the risks and potential benefits compared to my current standard follow-up care?
5Would joining this personalized surveillance protocol change or replace the monitoring plan my care team already has for me, or would it run alongside it — and is there a reason to consider standard surveillance first before enrolling?
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
Advanced neoplasia
Timeframe: Up to 5 years
Trial details
NCT IDNCT04678011
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)