RecruitingNCT07199127

Duodenal Polyposis Classification in FAP

Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

300 participants

Start Date

Feb 2, 2018

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

Histological grading of duodenal polyps incomplete
Follow-up data were unavailable
Duodenal surgery before study baseline endoscopy

Interventions

DIAGNOSTIC_TESTDRACO

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