Duodenal Polyposis Classification in FAP
Recruiting · NCT07199127 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
View the official record on ClinicalTrials.gov →Interventions studied
DRACO
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy
- IRCCS Ospedale San Raffaele - Milan, MI, Italy