RecruitingNCT04677998

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


Sponsor

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

Enrollment

1,000 participants

Start Date

Nov 24, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria3

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

Interventions

PROCEDUREPersonalized surveillance and intervention protocol

This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 3-6 months and 5 years, depending on severity of polyposis and performed endoscopic interventions.


Locations(2)

MD Anderson

Houston, Texas, United States

Academic Medical Centre

Amsterdam, North Holland, Netherlands

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NCT04677998


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