Actively Recruiting

Age: 18Years +
All Genders
ID04677998

A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-02-23

1000

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

L

Leiden University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP). FAP patients are at high risk for developing duodenal adenomas, which can lead to duodenal cancer in a small percentage of cases. The study aims to improve prevention of advanced neoplasia by removing lesions early, addressing concerns about current classification and treatment methods that may not adequately predict or prevent cancer. This study involves one group where participants receive endoscopic surveillance and interventions according to a personalized schedule. The intervals between endoscopies range from 3-6 months up to 5 years, depending on the severity of polyposis and previous treatments. The protocol focuses on monitoring and removing lesions to prevent cancer development and avoid the need for risky surgery. Participants will undergo regular endoscopic examinations and interventions as needed, with follow-up evaluations extending up to five years. Researchers will monitor the occurrence of advanced neoplasia, recurrence rates after different endoscopic treatments, intervention feasibility, diagnostic accuracy, complication rates, surveillance burden, and any surgeries performed. These assessments aim to provide comprehensive safety and effectiveness data for the personalized protocol.

CONDITIONS

Brief Title

A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of familial adenomatous polyposis (FAP) confirmed by genetic testing or clinical diagnosis
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Endoscopic removal of all polyps with an indication for removal not possible or feasible
  • Presence of gastric or duodenal cancer at baseline endoscopy
  • Need for surgery

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants undergo personalized endoscopic surveillance with intervals between 3 to 6 months and up to 5 years, depending on the severity of polyposis and performed endoscopic interventions.

Visits every 3 to 6 months to 5 years depending on individual surveillance intervals

Trial Site Locations

Total: 2 locations

1

MD Anderson

Houston, Texas, United States, 77030

Actively Recruiting

2

Academic Medical Centre

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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