Personalized care for patients with familial adenomatous polyposis
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT04677998 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a confirmed diagnosis of familial adenomatous polyposis.
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.
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 performed: While there have been studies addressing surveillance in FAP patients, this personalized approach is novel and aims to address specific limitations of existing protocols.
Eligibility criteria
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 this trial is running
Houston, Texas and 1 other locations
- MD Anderson — Houston, Texas, United States (Recruiting)
- Academic Medical Centre — Amsterdam, North Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.