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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Marco Vitellaro, M.D.
marco.vitellaro@istitutotumori.mi.it
+393480197920
Time Frame
Start Date: 2018-02-02
Estimated Completion Date: 2030-01-15
Participants
Target number of participants: 300
Treatments
Individuals with duodenal advanced neoplasia (Training cohort)
Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the training cohort (aka, cases)
Individuals with duodenal advanced neoplasia (validation cohort)
Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the validation cohort (aka, cases)
Individuals with duodenal advanced neoplasia (Testing cohort)
Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the testing cohort (aka, cases)
Individuals without duodenal advanced neoplasia (Training cohort)
Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the training cohort (aka, controls)
Individuals without duodenal advanced neoplasia (Validation cohort)
Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the validation cohort (aka, controls)
Individuals without duodenal advanced neoplasia (Testing cohort)
Individuals who remained free from duodenal or ampullary high-grade dysplasia and adenocarcinoma after the index EGD, within the testing cohort (aka, controls)
Related Therapeutic Areas
Familial Adenomatous Polyposis
Endoscopy
Sponsors
Collaborators: IRCCS Ospedale San Raffaele
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov

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