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Duodenal Polyposis Classification in FAP

NCT07199127 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Duodenum Cancer
  • Familial Adenomatous Polyposis
  • Duodenal Polyposis
  • Ampulla of Vater Adenoma
  • FAP Gene Mutation
  • FAP
  • Duodenal Neoplasms
  • Duodenal Adenoma
  • Ampulla of Vater Cancer

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)

Sponsors & Collaborators

  • IRCCS Ospedale San Raffaele

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Marco Vitellaro, M.D. · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2025-08-25
Completion
2030-01-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199127 on ClinicalTrials.gov