NCT04677998

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2020Nov 2027

First Submitted

Initial submission to the registry

November 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 23, 2026

Status Verified

August 1, 2025

Enrollment Period

5.9 years

First QC Date

November 24, 2020

Last Update Submit

February 20, 2026

Conditions

Familial Adenomatous Polyposis

Keywords

Endoscopic surveillanceEndoscopic interventionsPersonalized careGastrointestinal neoplasia

Outcome Measures

Primary Outcomes (1)

  • Advanced neoplasia

    Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer

    Up to 5 years

Secondary Outcomes (6)

  • Recurrences after different endoscopic intervention techniques

    Analysis at 2 years and 5 years

  • Feasibility of endoscopic interventions

    Analysis at 2 years and 5 years

  • Accuracy optical diagnosis

    Analysis at 2 years and 5 years

  • Complications

    Analysis at 2 years and 5 years

  • Surveillance burden

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (1)

Personalized surveillance and intervention protocol

Procedure: Personalized surveillance and intervention protocol

Interventions

Personalized surveillance and intervention protocolPROCEDURE

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.

Personalized surveillance and intervention protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with FAP treated at one of the participating centers will be assessed for eligibility.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Evelien Dekker, MD, PhD

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 21, 2020

Study Start

November 24, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

February 23, 2026

Record last verified: 2025-08

Locations

NL(1)US(1)