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RECRUITING
NCT07199127

Duodenal Polyposis Classification in FAP

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

View on ClinicalTrials.gov

Summary

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.

Official title: Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2018-02-02

Completion Date

2030-01-15

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

DRACO

A novel endoscopic classification to predict the risk of duodenal and ampullary high-grade dysplasia and cancer from baseline esophagogastroduodenoscopy (EGD)

Locations (2)

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy