NCT04678011

Brief 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.

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
6mo left

Started Nov 2021

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

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Study Timeline

Key milestones and dates

Study Progress90%
Nov 2021Nov 2026

First Submitted

Initial submission to the registry

November 24, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 23, 2026

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

November 24, 2020

Last Update Submit

February 20, 2026

Conditions

Familial Adenomatous Polyposis

Keywords

Endoscopic surveillanceEndoscopic interventionsPersonalised careGastrointestinal neoplasia

Outcome Measures

Primary Outcomes (1)

  • Advanced neoplasia

    Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size ≥ 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.

    Up to 5 years

Secondary Outcomes (6)

  • Characteristics polyps

    Up to 5 years

  • Radicality of different endoscopic intervention techniques

    Up to 5 years

  • Feasibility endoscopic interventions

    Up to 5 years

  • Surgical interventions

    Up to 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 6 months and 2 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

All patients with FAP treated at one of the participating centres.

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)
  • Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
  • Age 18 years or older

You may not qualify if:

  • Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
  • 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, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 23, 2026

Record last verified: 2025-09

Locations

NL(1)US(1)