Personalized care for patients with familial adenomatous polyposis
Official title: A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT04677998 · Data updated 2026-11-12
This study is testing a personalized care plan for people with familial adenomatous polyposis to see if it can better manage their duodenal and gastric polyps and reduce the need for surgery.
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, 2020 |
| Main results expected | November 2026 |
| Study ends | November 2027 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT04677998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older with a confirmed diagnosis of familial adenomatous polyposis.
✕Probably not a fit
Patients who have undergone endoscopic removal of all polyps or those with existing gastric or duodenal cancer 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 efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients diagnosed with familial adenomatous polyposis (FAP). Given the high risk of duodenal adenomas in FAP patients, the study seeks to improve upon the existing Spigelman classification system, which has limitations in predicting cancer risk. By implementing a tailored approach to surveillance and intervention, the researchers hope to enhance patient outcomes and reduce the need for surgical interventions, which carry significant risks. The study will involve monitoring patients and determining the best course of action based on individual assessments.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of duodenal cancer and improve the management of patients with familial adenomatous polyposis.
How similar studies have gone: While there have been studies addressing surveillance in FAP patients, this personalized approach is novel and aims to address specific limitations of existing protocols.
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) * Age 18 years or older Exclusion Criteria: * Endoscopic removal of all polyps with an indication for removal not possible/feasible * Gastric or duodenal cancer at baseline endoscopy * Need for surgery
Where it's running
-
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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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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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.