Duodenal Polyposis Classification in FAP

Recruiting now

Conditions studied: Duodenum Cancer, Familial Adenomatous Polyposis, Duodenal Polyposis, Ampulla of Vater Adenoma, FAP Gene Mutation, FAP, Duodenal Neoplasms, Duodenal Adenoma, Ampulla of Vater Cancer

In brief

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.

Key facts

Study ID

NCT07199127

Run by

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

People needed

300

Starts

2018-02-02

Expected to finish

2030-01-15

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Histological grading of duodenal polyps incomplete
• Follow-up data were unavailable
• Duodenal surgery before study baseline endoscopy

Where it is running

• IRCCS Ospedale San Raffaele — Milan, MI, Italy (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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