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Recruiting NCT07536841

Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis

— Observational Autoimmune Pancreatitis IgG4-Related Diseases Pancreatic Cancer Chronic Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention (observational study).
Who it may be relevant to
Registry conditions: Autoimmune Pancreatitis, IgG4-Related Diseases, Pancreatic Cancer, Chronic Pancreatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ukraine
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis

Overview

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.

Detailed description

The study uses an ambispective design, including both retrospective and prospective data collection.

Autoimmune pancreatitis (AIP) remains a diagnostic challenge due to its heterogeneous clinical presentation and overlap with pancreatic cancer and other inflammatory conditions. The Odesa Criteria 2026 (OC26) were developed as a flexible, domain-based point scoring system integrating four diagnostic domains: morphology, serology, clinical features, and histology. Each domain contributes weighted points toward a total diagnostic score, enabling structured and reproducible assessment across diverse patient phenotypes.

This ambispective observational study evaluates the diagnostic performance of OC26 in real-world clinical practice. The study assesses sensitivity, specificity, predictive values, likelihood ratios, and overall diagnostic accuracy using final clinical diagnosis as the reference standard. Additional analyses include interobserver agreement for domain scoring, diagnostic performance of individual domains, ROC curve analysis for the total OC26 score, and determination of the optimal diagnostic cut-off.

The study aims to validate OC26 as a practical, scalable, and reproducible diagnostic tool for autoimmune pancreatitis, supporting its implementation in routine clinical workflows and future international guideline development.

Interventions

  • Other No intervention (observational study)
    Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.

Primary outcome measures

  • Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis [Time frame: At completion of baseline diagnostic assessment]
Secondary outcome measures (4)
  • Interobserver agreement for OC26 domain scoring [Time frame: At completion of baseline diagnostic workup]
  • Diagnostic performance of individual OC26 domains [Time frame: At completion of baseline diagnostic workup]
  • ROC curve analysis for total OC26 score [Time frame: At completion of baseline diagnostic workup]
  • Optimal cut-off value for OC26 total score [Time frame: At completion of baseline diagnostic workup]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Ukraine · 2 centers
  • Military Medical Clinical Center of the Southern Region — Odesa
  • Military Medical Clinical Center of the Southern Region — Odesa

Publications

  • Hohenstein 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
  • Jones 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

Identifiers

NCT: NCT07536841 · OC26-AIP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗