Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment82 (estimated)
SponsorMilitary Medical Clinical Center of the Southern Region, Ukraine
Academic / other
Locations2 sites (Odesa and 1 other locations)
StatusRecruiting
StartedMay 1, 2026
Main results expectedMay 1, 2026
Study endsDecember 1, 2026
Registry record updatedMay 28, 2026
Trial IDNCT07536841 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.