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Duodenal Polyposis Classification in FAP

ConditionsDuodenum CancerFamilial Adenomatous PolyposisDuodenal PolyposisAmpulla of Vater AdenomaFAP Gene MutationFAPDuodenal NeoplasmsDuodenal AdenomaAmpulla of Vater Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Histological grading of duodenal polyps incomplete

Follow-up data were unavailable

Duodenal surgery before study baseline endoscopy

Trial population

Individuals with familial adenomatous polyposis, defined by a pathogenic/likely pathogenic germline Adenonomatous Polyposis Coli (APC) gene variant, undergoing surveillance for duodenal polyposis using esophagogastroduondeoscopy (EGD)

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • DRACO

    Diagnostic test

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

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Individuals with duodenal advanced neoplasia (Training cohort)1 intervention
Group B: Individuals with duodenal advanced neoplasia (validation cohort)1 intervention
Group C: Individuals with duodenal advanced neoplasia (Testing cohort)1 intervention
Group D: Individuals without duodenal advanced neoplasia (Training cohort)1 intervention
Group E: Individuals without duodenal advanced neoplasia (Validation cohort)1 intervention
Group F: Individuals without duodenal advanced neoplasia (Testing cohort)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

True Positivity Rate: the probability of a positive test result, conditioned on the individual truly developing duodenal or ampullary high-grade dysplasia or adenocarcinoma

Time frame
Through study completion, on average 5 years

Secondary outcomes

1

Specificity

True Negative Rate: the probability of a negative test result, conditioned on the individual being truly free from duodenal or ampullary high-grade dysplasia or adenocarcinoma

Time frame
Through study completion, on average 5 years
2

Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Time frame
Through study completion, on average 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

IRCCS Ospedale San Raffaele

Collaborator

Source ClinicalTrials.gov
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