Odesa Criteria 2026: tests for autoimmune pancreatitis diagnosis
Official title: Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis
Run by Military Medical Clinical Center of the Southern Region, Ukraine · NCT07536841 · Data updated 2026-11-12
This study checks if the OC26 scoring system can accurately diagnose autoimmune pancreatitis in adults who may have AIP or related pancreatic diseases.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Military Medical Clinical Center of the Southern Region, Ukraine Academic / other |
| Locations | 2 sites (Odesa and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07536841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) being evaluated for suspected autoimmune pancreatitis with sufficient data to score OC26.
✕Probably not a fit
Patients with alternative confirmed diagnoses or incomplete data may not benefit from this validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This ambispective observational study evaluates the diagnostic performance of the Odesa Criteria 2026 (OC26), a domain-based point scoring system for autoimmune pancreatitis. It analyzes how well OC26 works across clinical, serological, imaging, and histology data in real-world patients. The study uses both retrospective and prospective data to determine sensitivity, specificity, predictive values, and interobserver agreement, aiming to support routine use and guideline development. No interventions are performed; participants are assessed using existing data to score OC26. The investigation is conducted at the Military Medical Clinical Center of the Southern Region in Odesa, Ukraine.
Why it matters
Potential benefit: If OC26 proves accurate, clinicians may diagnose autoimmune pancreatitis more reliably and avoid unnecessary tests or surgeries.
How similar studies have gone: Previous domain-based scoring approaches in autoimmune pancreatitis have shown promise, but OC26 validation in real-world settings is ongoing.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Military Medical Clinical Center of the Southern Region
Odesa, Ukraine Recruiting -
Military Medical Clinical Center of the Southern Region
Odesa, Ukraine Recruiting
Study contacts
- Principal investigator: Oleg Dovbenko — Odesa Regional Clinical Medical Center
- Study coordinator: Oleg Dovbenko, MD, PhD
- Email: dovbenko2015@hotmail.com
- Phone: +380682539685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.