RecruitingNCT04678011

A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy


Sponsor

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

Enrollment

1,000 participants

Start Date

Nov 24, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
  • 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 6 months and 2 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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NCT04678011


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