Clinical trial · Observational
Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis
Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis
NCT07536841CI-TRIAL-00112852ОС26recruitingClinicalTrials.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)
This ambispective observational study aims to validate the Odesa Criteria 2026 (OC26), a flexible domain-based point scoring system for diagnosing autoimmune pancreatitis. The study evaluates diagnostic accuracy and reproducibility of OC26 across clinical, serological, morphological, and histological domains.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Pancreatitis | — | UNRESOLVED | — |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| IgG4-Related Diseases | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AIP Suspected Cohort
- description
- Patients evaluated for suspected autoimmune pancreatitis. Participants undergo standard clinical, serological, imaging, and histological assessment according to the Odesa Criteria 2026 (OC26). No interventions are assigned as this is an observational study.
- interventionNames
- Other: No intervention (observational study)
Primary outcomes (1)
- measure
- Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis
- timeFrame
- At completion of baseline diagnostic assessment
- description
- Evaluation of the diagnostic performance of the Odesa Criteria 2026 (OC26), a domain-based point scoring system for autoimmune pancreatitis (AIP). The analysis includes calculation of sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and overall diagnostic accuracy using final clinical diagnosis as the reference standard.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (≥18 years) undergoing evaluation for suspected autoimmune pancreatitis. * Availability of clinical, serological, imaging, and/or histological data required for OC26 scoring. * Ability to provide informed consent (for prospective participants). Exclusion Criteria: * Confirmed alternative diagnosis explaining pancreatic findings (e.g., pancreatic cancer, acute pancreatitis of other etiology). * Incomplete diagnostic data preventing OC26 scoring. * Prior pancreatic surgery altering diagnostic interpretation.
References
Publications (2)
- BACKGROUNDHohenstein B, Colin M, Foellmer C, Amann KU, Brekken RA, Daniel C, Hugo CP. Autocrine VEGF-VEGF-R loop on podocytes during glomerulonephritis in humans. Nephrol Dial Transplant. 2010 Oct;25(10):3170-80. doi: 10.1093/ndt/gfq200. Epub 2010 Apr 15. PMID 20395257
- BACKGROUNDJones CJ, Larive CK. Could smaller really be better? Current and future trends in high-resolution microcoil NMR spectroscopy. Anal Bioanal Chem. 2012 Jan;402(1):61-8. doi: 10.1007/s00216-011-5330-7. Epub 2011 Aug 31. PMID 21879299