Personalized care for patients with Familial Adenomatous Polyposis after surgery
Official title: A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT04678011 · Data updated 2026-11-12
This study is testing a personalized follow-up plan for people with familial adenomatous polyposis who have had surgery to see if it helps prevent cancer and manage their health better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | November 24, 2021 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT04678011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have a confirmed diagnosis of FAP and have undergone prophylactic (procto)colectomy.
✕Probably not a fit
Patients who have active cancer at baseline endoscopy or those unable to have polyps removed during endoscopic procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness and safety of a personalized surveillance and intervention protocol for patients diagnosed with familial adenomatous polyposis (FAP) who have undergone prophylactic (procto)colectomy. FAP is a genetic condition that leads to the development of numerous polyps in the colon and rectum, significantly increasing the risk of colorectal cancer. The study will monitor patients post-surgery to manage and prevent the progression of adenomas and potential cancer development through tailored endoscopic surveillance and interventions. Participants will be followed over time to assess the outcomes of this personalized approach.
Why it matters
Potential benefit: If successful, this protocol could significantly reduce the risk of colorectal cancer in patients with FAP by providing tailored surveillance and intervention strategies.
How similar studies have gone: While personalized surveillance approaches have been explored in other contexts, this specific protocol for FAP post-surgery is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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MD Anderson
Houston, Texas, United States Recruiting -
Academic Medical Centre
Amsterdam, North Holland, Netherlands Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Classifying duodenal polyps in familial adenomatous polyposis
This project will test two risk models to see if they better predict dangerous duodenal polyps and cancer risk in people with genetically confirmed FAP.
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Personalized home treadmill exercise for people with Familial Adenomatous Polyposis (FAP)
This trial will try different amounts of home treadmill exercise in people with FAP who have at least five rectal polyps to see if exercise can help prevent polyps from coming back.
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Investigating factors that influence polyp development in patients with Familial Adenomatous Polyposis
This study looks at how gut bacteria and environmental factors might affect polyp growth in people with Familial Adenomatous Polyposis who have had preventive surgery and regular check-ups.
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TPST-1495 treatment for people with familial adenomatous polyposis
This trial will try an oral drug called TPST-1495 to see if it reduces the number of polyps in the small bowel and colon in people with familial adenomatous polyposis.
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10 cm versus 15 cm J-shaped ileal pouch after IPAA surgery
This trial will see if a 10 cm or a 15 cm J-pouch gives better bowel function and quality of life for people having IPAA for ulcerative colitis or familial adenomatous polyposis.
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ONC201 (dordaviprone) for safety and prevention of colorectal polyps in high-risk adults.
This trial tests whether different doses of ONC201 (dordaviprone) are safe and can help prevent new colorectal polyps in adults with familial adenomatous polyposis or a history of multiple adenomas.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.