|

Duodenal Polyposis Classification in FAP

RECRUITINGSponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Actively Recruiting
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Started2018-02-02
Est. completion2025-08-25
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07199127

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions10

Ampulla of Vater AdenomaAmpulla of Vater CancerCancerDuodenal AdenomaDuodenal NeoplasmsDuodenal PolyposisDuodenum CancerFAPFAP Gene MutationFamilial Adenomatous Polyposis

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.