ClinicalTrials.gov record NCT07536841

Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUkraine
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This ambispective observational study evaluates the Odesa Criteria 2026 (OC26), a domain-based point score for diagnosing autoimmune pancreatitis. It uses both retrospective cases and prospectively collected patients to measure how accurately and reproducibly OC26 identifies autoimmune pancreatitis compared with the final clinical diagnosis. The study examines each diagnostic domain (morphology, serology, clinical features, histology) and seeks an optimal total-score cut-off.

What it is studying. The study tests the diagnostic performance of the OC26 scoring system across four domains (morphology, serology, clinical features, histology). It measures accuracy statistics (sensitivity, specificity, predictive values, likelihood ratios), interobserver agreement, ROC curve performance, and determines an optimal diagnostic cut-off using the final clinical diagnosis as the reference standard.

What the researchers hope to learn. To validate OC26 as a practical, scalable, and reproducible diagnostic tool for autoimmune pancreatitis by reporting diagnostic accuracy, domain-level performance, interobserver agreement, ROC/AUC, and an optimal score cut-off. Results aim to inform clinical use and future guideline development.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • No intervention (observational study)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational study using routine clinical information. Participants’ existing or newly collected diagnostic data (medical history, blood tests/serology, pancreatic imaging such as CT/MRI or endoscopic ultrasound when done, and any biopsies/tissue taken as part of care) will be reviewed and scored using the Odesa Criteria 2026. No study-assigned treatment is given. Some participants are included from past records (retrospective) and others are enrolled prospectively and asked to consent to collection and review of their diagnostic information.

How the study is structured. Ambispective cohort observational study: existing medical records are reviewed and new patients evaluated for suspected autoimmune pancreatitis are followed. No study-assigned treatments are given; diagnostic assessment follows routine clinical practice. Investigators compare OC26 scores to the final clinical diagnosis and assess reproducibility between reviewers.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Ukraine. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 1, 2026
Primary completion
May 1, 2026
Study completion
Dec 1, 2026 (estimated)
Target enrollment
82 participants (estimated)
Last updated on registry
May 28, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Military Medical Clinical Center of the Southern Region, Ukraine
Principal investigator
Oleg Dovbenko, MD, Head of Endoscopic Surgery Department
Military Medical Clinical Center of the Southern Region, Ukraine

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials