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

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

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 design

Treatments tested in this trial

  • Personalized surveillance and intervention protocol

Treatment groups

1,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

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