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Clinical Trials in Italy / NCT07199127
Recruiting Observational

Duodenal Polyposis Classification in FAP

NCT07199127 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase
Observational
Started
2018-02-02
Last updated
2025-09-30

Condition(s) studied

Duodenum CancerFamilial Adenomatous PolyposisDuodenal PolyposisAmpulla of Vater AdenomaFAP Gene MutationFAPDuodenal NeoplasmsDuodenal AdenomaAmpulla of Vater Cancer

Investigational drug(s) / intervention(s)

DRACO

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele Milan MI Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy Recruiting

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Other trials for the same condition

A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination With L19-IL2 as a Treatment of Metastatic FAP-positive Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199127 on ClinicalTrials.gov ↗ ← All trials in Italy