Duodenal Polyposis Classification in FAP

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.

NCT Number	NCT07199127
Lead Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Collaborators: IRCCS Ospedale San Raffaele
Conditions	Duodenum Cancer, Familial Adenomatous Polyposis, Duodenal Polyposis, Ampulla of Vater Adenoma, FAP Gene Mutation, FAP, Duodenal Neoplasms, Duodenal Adenoma +1 more
Enrollment	300 participants
Start Date	2018-02-02
Primary Completion	2025-08-25 (estimated)
Study Completion	2030-01-15 (estimated)
Updated on ClinicalTrials.gov	2025-09-30