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

ConditionFamilial Adenomatous Polyposis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Endoscopic removal of all polyps with an indication for removal not possible/feasible

Gastric or duodenal cancer at baseline endoscopy

Need for surgery

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Personalized surveillance and intervention protocol

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Personalized surveillance and intervention protocol1 intervention

Trial outcomes

Primary outcomes

1

Advanced neoplasia

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

Time frame
Up to 5 years

Secondary outcomes

1

Recurrences after different endoscopic intervention techniques

Incidence of recurrences after endoscopic interventions after en bloc/piecemeal resection and different techniques such as cold snare polypectomy or endoscopic mucosal resection with or without lifting

Time frame
Analysis at 2 years and 5 years
2

Feasibility of endoscopic interventions

Incidence of lesions not amenable to endoscopic removal

Time frame
Analysis at 2 years and 5 years
3

Accuracy optical diagnosis

The ability of endoscopists to optically diagnose duodenal and gastric lesions. Sensitivity and specificity for optically diagnose high-grade dysplasia in the stomach and duodenum.

Time frame
Analysis at 2 years and 5 years
4

Complications

Incidence of endoscopy related complications

Time frame
Analysis at 2 years and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Leiden University Medical Center

Collaborator

The Netherlands Cancer Institute

Collaborator

St Mark's Hospital Foundation

Collaborator

Hospital Clinic of Barcelona

Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborator

Hospital General Universitario de Alicante

Collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborator

Radboud University Medical Center

Collaborator

University Hospital, Bonn

Collaborator

Hvidovre University Hospital

Collaborator

M.D. Anderson Cancer Center

Collaborator

Source ClinicalTrials.gov
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