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.
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
Histological grading of duodenal polyps incomplete
Follow-up data were unavailable
Duodenal surgery before study baseline endoscopy
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Treatment groupsSee each treatment group below.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
IRCCS Ospedale San Raffaele
Collaborator