Duodenal Polyposis Classification in FAP
Recruiting
Observational Study
Duodenum Cancer
Familial Adenomatous Polyposis
Duodenal Polyposis
Ampulla of Vater Adenoma
FAP Gene Mutation
FAP
Duodenal Neoplasms
Duodenal Adenoma
Ampulla of Vater Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 300 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
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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 fr…
Trial Locations
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Eligibility Criteria
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 …
Contacts