Actively Recruiting
Duodenal Polyposis Classification in FAP
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-09-30
300
Participants Needed
2
Research Sites
623 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
I
IRCCS Ospedale San Raffaele
Collaborating Sponsor
AI-Summary
What this Trial Is About
Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy for advanced neoplasia. The DRACO study (Duodenal Risk Assessment in adenomatous polyposis Coli -Oncogene) is a multicenter, STROBE- and CONSORT-compliant cohort study that analyzes upper endoscopies from genetically confirmed FAP patients across independent cohorts to develop, validate, and externally test two multivariable risk models.
CONDITIONS
Official Title
Duodenal Polyposis Classification in FAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed germline diagnosis of familial adenomatous polyposis (FAP) by genetic testing
- Two or more upper gastrointestinal endoscopies completed
- Complete documentation of all Spigelman classification variables at each endoscopic evaluation
You will not qualify if you...
- Incomplete histological grading of duodenal polyps
- Unavailable follow-up data
- Duodenal surgery performed before the study baseline endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
IRCCS Ospedale San Raffaele
Milan, MI, Italy, 20129
Actively Recruiting
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
Research Team
M
Marco Vitellaro, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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