Clinical trial · Observational
Duodenal Polyposis Classification in FAP
Novel Endoscopic Classification for Duodenal Polyposis in Individuals With Familial Adenomatous Polyposis
NCT07199127CI-TRIAL-00095960DRACOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
| Ampulla of Vater Cancer | Malignant Ampulla of Vater Neoplasm | CURATED_BROADER | 0.80 |
| Duodenal Adenoma | Duodenal Non-Ampullary Adenoma | ALIAS | 0.90 |
| Duodenal Neoplasms | Duodenal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Duodenal Polyposis | — | UNRESOLVED | — |
| Duodenum Cancer | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
| FAP | — | UNRESOLVED | — |
| FAP Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DRACO | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Individuals with duodenal advanced neoplasia (Training cohort)
- description
- Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the training cohort (aka, cases)
- interventionNames
- Diagnostic Test: DRACO
- label
- Individuals with duodenal advanced neoplasia (validation cohort)
- description
- Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the validation cohort (aka, cases)
- interventionNames
- Diagnostic Test: DRACO
- label
- Individuals with duodenal advanced neoplasia (Testing cohort)
- description
- Individuals who developed biopsy-confirmed duodenal or ampullary high-grade dysplasia (HGD) or adenocarcinoma after the index EGD, within the testing cohort (aka, cases)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDBulow S, Christensen IJ, Hojen H, Bjork J, Elmberg M, Jarvinen H, Lepisto A, Nieuwenhuis M, Vasen H. Duodenal surveillance improves the prognosis after duodenal cancer in familial adenomatous polyposis. Colorectal Dis. 2012 Aug;14(8):947-52. doi: 10.1111/j.1463-1318.2011.02844.x. PMID 21973191
- BACKGROUNDZaffaroni G, Mannucci A, Koskenvuo L, de Lacy B, Maffioli A, Bisseling T, Half E, Cavestro GM, Valle L, Ryan N, Aretz S, Brown K, Buttitta F, Carneiro F, Claber O, Blanco-Colino R, Collard M, Crosbie E, Cunha M, Doulias T, Fleming C, Heinrich H, Huneburg R, Metras J, Nagtegaal I, Negoi I, Nielsen M, Pellino G, Ricciardiello L, Sagir A, Sanchez-Guillen L, Seppala TT, Siersema P, Striebeck B, Sampson JR, Latchford A, Parc Y, Burn J, Moslein G. Updated European guidelines for clinical management of familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), gastric adenocarcinoma, proximal polyposis of the stomach (GAPPS) and other rare adenomatous polyposis syndromes: a joint EHTG-ESCP revision. Br J Surg. 2024 May 3;111(5):znae070. doi: 10.1093/bjs/znae070. PMID 38722804
- BACKGROUNDMannucci A, Puzzono M, Goel A, Moslein G, Balafas S, Di Serio MS, Cavestro GM. The Spigelman Staging System and the Risk of Duodenal and Papillary Cancer in Familial Adenomatous Polyposis: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2024 Apr 1;119(4):617-624. doi: 10.14309/ajg.0000000000002688. Epub 2024 Jan 31. PMID 38294150
- RESULTKarstensen JG, Bulow S, Hojen H, Jelsig AM, Jespersen N, Andersen KK, Wewer MD, Burisch J, Pommergaard HC. Cancer in Patients With Familial Adenomatous Polyposis: A Nationwide Danish Cohort Study With Matched Controls. Gastroenterology. 2023 Sep;165(3):573-581.e3. doi: 10.1053/j.gastro.2023.05.010. Epub 2023 May 16. PMID 37201686