Actively Recruiting
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-02-23
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) who have undergone prophylactic (procto)colectomy. FAP causes numerous polyps in the colon and rectum, leading to nearly certain colorectal cancer if untreated. Surgery such as restorative proctocolectomy or subtotal colectomy is performed to reduce cancer risk, but lifelong monitoring is needed due to the risk of new adenomas developing in remaining tissues. This study aims to provide evidence for tailored endoscopic surveillance intervals to prevent advanced neoplasia by removing lesions early. Participants will follow a personalized endoscopic surveillance schedule with intervals ranging from 6 months to 2 years, based on the severity of their polyposis and endoscopic interventions performed. They will undergo regular endoscopic examinations to monitor and remove polyps larger than 5mm as recommended by guidelines. This one-arm observational study focuses on how personalized timing of surveillance affects outcomes after (procto)colectomy with IRA/ISA or IPAA. During the study, participants will have endoscopic assessments to track the development of advanced neoplasia and characteristics of polyps. Researchers will evaluate the effectiveness and feasibility of different endoscopic removal techniques, the need for additional surgery, surveillance burden, and any complications over up to five years. This long-term monitoring aims to improve personalized care and optimize surveillance strategies for FAP patients post-surgery.
CONDITIONS
Brief Title
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of familial adenomatous polyposis (FAP) confirmed by genetic testing (APC germline mutation) or clinical diagnosis (more than 100 colorectal adenomas with positive family history of FAP)
- Have undergone prophylactic (procto)colectomy surgery with ileorectal anastomosis (IRA), ileosigmoidal anastomosis (ISA), or ileal pouch-anal anastomosis (IPAA)
- Age 18 years or older
You will not qualify if you...
- Unable to remove all polyps that need removal during one or multiple clearing endoscopies
- Presence of cancer at baseline endoscopy
- Need for surgery at the start of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants undergo personalized endoscopic surveillance with intervals between 6 months and 2 years, depending on the severity of polyposis and previous endoscopic interventions.
Endoscopic visits every 6 months to 2 years depending on condition
Trial Site Locations
Total: 2 locations
1
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
2
Academic Medical Centre
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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