Classifying duodenal polyps in familial adenomatous polyposis
Official title: Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis
Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT07199127 · Data updated 2026-11-12
This project will test two risk models to see if they better predict dangerous duodenal polyps and cancer risk in people with genetically confirmed FAP.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Status | Recruiting |
| Started | February 2, 2018 |
| Main results expected | August 25, 2025 |
| Study ends | January 15, 2030 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT07199127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with a germline FAP diagnosis who have had two or more upper endoscopies with complete Spigelman data and no prior duodenal surgery are the ideal candidates.
✕Probably not a fit
Patients without genetic confirmation of FAP, with only a single recorded endoscopy, incomplete Spigelman data, or who had duodenal surgery before the baseline endoscopy are unlikely to benefit from the models.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The DRACO cohort collects and harmonizes upper endoscopy data from genetically confirmed FAP patients across multiple centers to develop and validate two multivariable risk models for duodenal neoplasia. The study follows STROBE and CONSORT principles and requires at least two documented upper endoscopies with complete Spigelman variables per participant. Models will be trained, internally validated, and externally tested in independent cohorts to predict high-grade dysplasia and duodenal cancer more accurately than the Spigelman staging system. Analyses focus on polyp size, number, histology, dysplasia grade, and longitudinal progression to identify patients who may benefit from earlier endoscopic treatment or surgery.
Why it matters
Potential benefit: If successful, these models could identify higher-risk patients earlier so clinicians can offer targeted endoscopic therapies or timely surgery and potentially reduce duodenal cancer deaths.
How similar studies have gone: Although the Spigelman system is widely used, prior studies show limited sensitivity for cancer and few large multicenter validations of multivariable prediction models exist, so this approach is relatively novel and designed to fill that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed germline diagnosis of FAP, as defined by genetic testing * Two or more upper gastrointestinal endoscopies * Complete documentation of all Spigelman classification variables at each endoscopic evaluation Exclusion Criteria: * Histological grading of duodenal polyps incomplete * Follow-up data were unavailable * Duodenal surgery before study baseline endoscopy
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Mi, Italy Recruiting -
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy Recruiting
Study contacts
- Study coordinator: Marco Vitellaro, M.D.
- Email: marco.vitellaro@istitutotumori.mi.it
- Phone: +393480197920
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.