Status:
RECRUITING
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Leiden University Medical Center
The Netherlands Cancer Institute
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
18+ years
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 (p...
Detailed Description
Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
- Cancer at baseline endoscopy
- Need for surgery
Key Trial Info
Start Date :
November 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04678011
Start Date
November 24 2021
End Date
November 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Academic Medical Centre
Amsterdam, North Holland, Netherlands, 1105AZ