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Duodenal Polyposis Classification in FAP

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Istituto Nazionale dei Tumori, M…
NCT07199127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • DRACO
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Where

2 sites
IRCCS Ospedale San Raffaele
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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