Health TrialsbyHealthPanel

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

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 personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.

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)

Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA

Age 18 years or older

Disqualifiers

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

Cancer at baseline endoscopy

Need for surgery

Trial population

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

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 6 months and 2 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 (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.

Time frame
Up to 5 years

Secondary outcomes

1

Characteristics polyps

Incidence and characteristics of polyps detected/removed in patients with IRA/ISA and IPAA

Time frame
Up to 5 years
2

Radicality of different endoscopic intervention techniques

Rate of radical endoscopic interventions

Time frame
Up to 5 years
3

Feasibility endoscopic interventions

Incidence of lesions not amenable to endoscopic removal

Time frame
Up to 5 years
4

Surgical interventions

Incidence of surgical interventions

Time frame
Up to 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

Hvidovre University Hospital

Collaborator

M.D. Anderson Cancer Center

Collaborator

University Hospital, Bonn

Collaborator

Source ClinicalTrials.gov
Apply now