NCT07199127Recruiting
Duodenal Polyposis Classification in FAP
Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- Feb 2018
- Primary completion date
- Aug 2025
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- NCT number
- NCT07199127
What you commit to
- Study type: Observational
- Planned participants: 300
- From Feb 2018 to the primary completion date, Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Duodenal surgery before study baseline endoscopy
Other
- Histological grading of duodenal polyps incomplete
- Follow-up data were unavailable
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.