Autoimmune PancreatitisОС26NCT07536841
Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis
An observational study of Autoimmune Pancreatitis and IgG4-Related Diseases, run by Military Medical Clinical Center of the Southern Region, Ukraine at 2 sites in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Pancreatitis, IgG4-Related Diseases, Pancreatic Cancer
- How many people
- 82 participants
- Where
- 2 sitesUkraine
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing diagnostic evaluation for suspected autoimmune pancreatitis at a tertiary referral center. The study includes both retrospective cases with complete diagnostic data and prospective participants evaluated according to the Odesa Criteria 2026 (OC26).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine2 sites, 2 recruiting
- Recruiting
Military Medical Clinical Center of the Southern Region
Odesa
Oleh Dovbenko, MD, PhD, 0682539685, dovbenko2015@hotmail.com
- Recruiting
Military Medical Clinical Center of the Southern Region
Odesa
Oleg Dovbenko, MD, PhD, +380682539685, dovbenko2015@hotmail.com
Oleg Dovbenko, MD, PhD, +380682539685, dovbenko73@gmail.com
About this study
Official title: Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis
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.
Read the 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.
- Being tested
- No intervention (observational study)
- Keywords
- AIP, IgG4, Autoimmune pancreatitis diagnosis, Pancreatic imaging, Endoscopic ultrasound, Serum protein fractions, IgG6/IgG8 ratio, Odesa Criteria 2026 (OC26), EUS Doppler
- Medical subject headings
- Autoimmune Pancreatitis, Immunoglobulin G4-Related Disease, Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| AIP Suspected Cohort | 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis
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.
Measured: At completion of baseline diagnostic assessment
Secondary outcomes (4)
Interobserver agreement for OC26 domain scoring
Assessment of interobserver agreement for each domain of the Odesa Criteria 2026 (OC26), including morphology, serology, clinical features, and histology. Agreement will be quantified using Cohen's kappa (κ) statistics for categorical items and intraclass correlation coefficients (ICC) for continuous or ordinal components. The analysis evaluates reproducibility of domain-level scoring among independent reviewers.
Measured: At completion of baseline diagnostic workup
Diagnostic performance of individual OC26 domains
Evaluation of the diagnostic performance of each OC26 domain (morphology, serology, clinical, histology) in identifying autoimmune pancreatitis. For each domain, sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve (AUC) will be calculated using final clinical diagnosis as the reference standard.
Measured: At completion of baseline diagnostic workup
ROC curve analysis for total OC26 score
Receiver operating characteristic (ROC) curve analysis of the total OC26 score to determine its discriminative ability for diagnosing autoimmune pancreatitis. The area under the curve (AUC) will be calculated, and performance will be compared across predefined subgroups.
Measured: At completion of baseline diagnostic workup
Optimal cut-off value for OC26 total score
Determination of the optimal diagnostic cut-off for the OC26 total score using Youden's index and other threshold-optimization methods. Sensitivity, specificity, and accuracy at the optimal cut-off will be reported.
Measured: At completion of baseline diagnostic workup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026
- Primary completion1 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Medical Clinical Center of the Southern Region, Ukraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleg Dovbenko, MD, Military Medical Clinical Center of the Southern Region, Ukraine
- Investigators
- Oleg Dovbenko, Principal investigator, Odesa Regional Clinical Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536841
- Sponsor's protocol ID
- OC26-AIP
- Acronym
- ОС26
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive clinical information and the dataset is not intended for external distribution. Only aggregated, de-identified results will be available in publications.
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.
PubMed 20395257Jones 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.
PubMed 21879299
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis
- ClinicalTrials.gov ID
- NCT07536841
- Acronym / sponsor ID
- ОС26 / OC26-AIP
- Keywords
- AIP, IgG4, Autoimmune pancreatitis diagnosis, Pancreatic imaging, Endoscopic ultrasound, Serum protein fractions, IgG6/IgG8 ratio, Odesa Criteria 2026 (OC26)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Military Medical Clinical Center of the Southern Region, UkraineUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIP Suspected Cohort | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing diagnostic evaluation for suspected autoimmune pancreatitis at a tertiary referral center. The study includes both retrospective cases with complete diagnostic data and prospective participants evaluated according to the Odesa Criteria 2026 (OC26).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice. | Other | AIP Suspected Cohort |
Primary outcome
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 20395257Hohenstein 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.
- Background: PubMed 21879299Jones 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive clinical information and the dataset is not intended for external distribution. Only aggregated, de-identified results will be available in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleg Dovbenko principal investigator
Odesa Regional Clinical Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Pancreatitis and IgG4-Related Diseases, run by Military Medical Clinical Center of the Southern Region, Ukraine at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg Dovbenko, MD, PhD (+380682539685, dovbenko2015@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.