Recruiting

Personalized Surveillance

Sponsor:

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

Code:

NCT04677998

Conditions

Familial Adenomatous Polyposis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personalized surveillance and intervention protocol

Study Details

Brief 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)

Conditions

Familial Adenomatous Polyposis

Study ID

NCT04677998

Start date

Nov 24, 2020

Status verified date

Aug, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Personalized surveillance and intervention protocol

Interventions

Personalized 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.

Primary outcome measure

  • Advanced neoplasia [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Annie Lincoln

+1 919 923 4430aglincoln@mdanderson.org

Principal Investigator:

Luigi Ricciardiello

More Information

Sponsor

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

Last update posted

Feb 23, 2026

Last verified

Aug, 2025

Keywords

  • Endoscopic surveillance
  • Endoscopic interventions
  • Personalized care
  • Gastrointestinal neoplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) on 2026-02-23.