Acute PancreatitisMoSAICNCT05878236
iMmune SignAtures and Clinical outComes in AP
An observational study of Acute Pancreatitis, run by Ohio State University at 5 sites in United States.
Trial summary
The MoSAIC study is a prospective, observational study designed to develop an early prediction tool for severe acute pancreatitis (SAP) and define a distinct immunologic profile compared to moderate acute pancreatitis (MAP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- CyTOF Analysis
- How many people
- 198 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Mar 2023to 31 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who meet all inclusion and no exclusion criteria will be considered for enrollment. Patients presenting to the hospital or emergency room with acute pancreatitis (AP) will be screened and enrolled within 36 hours of presentation to capture relevant biomarker information as early in their episode of AP as possible. Patients with chronic calcific pancreatitis, severe systemic illness confounding severity assessments or immunological outcomes, or anyone with an altered or compromised immune system will be excluded from enrollment.
Who may be able to join
- Age 18-75 years at the time of enrollment
- Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria (see definition below)
- Participant is approached by the research team within 36 hours of presentation to the hospital
- Participant fully understands and agrees to participate in all aspects of the study, including providing informed consent, completion of interviews and data forms, and collection of biospecimens
- Acute pancreatitis is defined/diagnosed using the revised Atlanta criteria, which requires the presence of at least two of the following criteria:
- Upper abdominal pain ii. Elevation of serum amylase or lipase level to >/=3 times the upper limit of normal iii. Features of AP on cross-sectional imaging.
Who cannot join
- Diagnosis of definite chronic pancreatitis (CP) at enrollment (see also study definitions) based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP):
- Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular) ii. Intraductal filling defects suggestive of calcifications on MRI and/or MRCP iii. Non-contrast imaging is acceptable for the assessment of definite CP, but calcifications noted by endoscopic ultrasound only (and not correlated with CT) are not considered definite CP. Patients with autoimmune pancreatitis, but no evidence of calcifications, may still be enrolled, assuming they satisfy inclusion criteria for 'diagnosis of AP'
- Potential participants with post-ERCP AP who are expected to be hospitalized for less than 48 hours.
- Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.
- Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment).
- Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, and Frey procedure.
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- Severe systemic illness that in the judgment of the investigative team will confound outcome assessments and immunological outcomes or pose additional risk for harm, including the history of solid organ transplant, acquired immunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with eGFR <30 or on dialysis prior to AP, and cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of <12 months.
- Known pregnancy at the time of enrollment.
- Incarceration.
- Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Haya Alrashdan, MSN, 312-413-0306, halras2@uic.edu
Cemal Yazici, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Zoe Krebs, BA, 614-685-3619, zoe.krebs@osumc.edu
Samantha Terhorst, MS, 614-685-3618, samantha.terhorst@osumc.edu
- Not yet recruiting
University of Southern California
Los Angeles, California, 90033
Alejandro Vazquez, alejandro.vazquez@med.usc.edu
Dara Bruce, dara.bruce@med.usc.edu
- Not yet recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Anna Phillips, MD, 412-864-7096, evansac3@upmc.edu
Nicole Ru, 4126249310, nir139@pitt.edu
- Not yet recruiting
Benaroya Research Institute
Seattle, Washington, 98101
Rachel Hartley, 206-341-8943, rhartley@benaroyaresearch.org
Cate Speake, PhD
About this study
Official title: iMmune SignAtures and Clinical outComes in Acute Pancreatitis: the MoSAIC Study
The MoSAIC study is a prospective, observational study designed to develop an early prediction tool for severe acute pancreatitis (SAP) and define a distinct immunologic profile compared to moderate acute pancreatitis (MAP). The aims are to validate a new multi-cytokine panel for early prediction of SAP and to identify the specific immune cells that correspond with cytokine signatures in early acute pancreatitis to characterize the immune pathways driving the development of SAP. Participants will provide blood samples and complete patient surveys and interviews within 36 hours of hospital presentation, at 48 hours, and hospital day 7 (if admitted). Data on hospital stay, medical history, clinical course, and severity of disease will be collected.
Read the detailed description
All participants will sign an informed consent before participating in the study. Adult subjects of both sexes and belonging to all ethnicities will be enrolled. Participants will consent for access to their electronic health records, complete study questionnaires, undergo serial clinical laboratory testing and provide biospecimens during their acute pancreatitis (AP) hospitalization. The research team will access the electronic health records for 5 years from the time of enrollment in the study.
The study network is comprised of five academic sites. Four sites will enroll AP patients [OSU, University of Illinois in Chicago Hospital (UIC), University of Pittsburgh Medical Center (UPMC), and the Keck Hospital of the University of Southern California (USC)]. The fifth site, the Benaroya Research Institute (BRI) will coordinate biospecimen handling for analyses, perform bioinformatics and serve as the biospecimen coordinating center (BCC). Each enrolling site will collect and ship biosamples to BRI. The blood samples collected in this study will be deposited into the Benaroya Research Institute (BRI) Immune-Mediated Diseases Registry and Repository (IMDRR). Participation in the repository is a requirement for inclusion in the study. Specimens collected in this study will be used for immune assays. Samples will also be coded and stored for up to 15 years in the IMDRR. Samples may be used to evaluate additional responses as new research tools become available or exploratory hypotheses are generated. OSU will serve as the data coordinating center (DCC). Coordinators at enrolling sites will enter study data into a secure cloud-based electronic database, and the DCC will be in charge of monitoring the quality and completeness of the electronic data.
- Conditions
- Acute Pancreatitis
- Being tested
- CyTOF Analysis
- Keywords
- Acute Pancreatitis, Immunology, MoSAIC
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyTOF AnalysisDiagnostic test
CyTOF laboratory testing for cytokine levels to correlate with severity of acute pancreatitis
| Study group | Role | What they receive |
|---|---|---|
| Acute Pancreatitis | Patients meeting Revised Atlanta Criteria for diagnosis of acute pancreatitis Receives: Diagnostic Test: CyTOF Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-Cytokine Panel Validation
Validate a novel multi-cytokine panel for early prediction of severe acute pancreatitis. The panel includes IL-8, TNFa R1, HGF, Resistin and Angiopoietin-2.
Measured: 4 years
Cytokine Signature Correlation
Correlate temporal cytokine signatures with disease severity. We will be correlating the above cytokines as well Il-6 and MCP-1.
Measured: 4 years
Secondary outcomes (2)
Circulating Immune Cells
Identify circulating immune cells that correspond with cytokine signatures in early acute pancreatitis
Measured: 4 years
Immune Pathways
Characterize the immune pathways driving the development of severe acute pancreatitis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start6 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Illinois Chicago, University of Southern California, Benaroya Research Institute
- Responsible party
- Principal investigator, George Papachristou, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878236
- Sponsor's protocol ID
- 2022H0394
- Acronym
- MoSAIC
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMmune SignAtures and Clinical outComes in Acute Pancreatitis: the MoSAIC Study
- ClinicalTrials.gov ID
- NCT05878236
- Acronym / sponsor ID
- MoSAIC / 2022H0394
- Conditions
- Acute Pancreatitis
- Keywords
- Acute Pancreatitis, Immunology, MoSAIC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Illinois Chicago, University of Southern California, Benaroya Research Institute
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2023 (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.
The MoSAIC study is a prospective, observational study designed to develop an early prediction tool for severe acute pancreatitis (SAP) and define a distinct immunologic profile compared to moderate acute pancreatitis (MAP). The aims are to validate a new multi-cytokine panel for early prediction of SAP and to identify the specific immune cells that correspond with cytokine signatures in early acute pancreatitis to characterize the immune pathways driving the development of SAP. Participants will provide blood samples and complete patient surveys and interviews within 36 hours of hospital presentation, at 48 hours, and hospital day 7 (if admitted). Data on hospital stay, medical history, clinical course, and severity of disease will be collected.
Detailed description
All participants will sign an informed consent before participating in the study. Adult subjects of both sexes and belonging to all ethnicities will be enrolled. Participants will consent for access to their electronic health records, complete study questionnaires, undergo serial clinical laboratory testing and provide biospecimens during their acute pancreatitis (AP) hospitalization. The research team will access the electronic health records for 5 years from the time of enrollment in the study.
The study network is comprised of five academic sites. Four sites will enroll AP patients [OSU, University of Illinois in Chicago Hospital (UIC), University of Pittsburgh Medical Center (UPMC), and the Keck Hospital of the University of Southern California (USC)]. The fifth site, the Benaroya Research Institute (BRI) will coordinate biospecimen handling for analyses, perform bioinformatics and serve as the biospecimen coordinating center (BCC). Each enrolling site will collect and ship biosamples to BRI. The blood samples collected in this study will be deposited into the Benaroya Research Institute (BRI) Immune-Mediated Diseases Registry and Repository (IMDRR). Participation in the repository is a requirement for inclusion in the study. Specimens collected in this study will be used for immune assays. Samples will also be coded and stored for up to 15 years in the IMDRR. Samples may be used to evaluate additional responses as new research tools become available or exploratory hypotheses are generated. OSU will serve as the data coordinating center (DCC). Coordinators at enrolling sites will enter study data into a secure cloud-based electronic database, and the DCC will be in charge of monitoring the quality and completeness of the electronic data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Pancreatitis | – | Diagnostic Test: CyTOF AnalysisPatients meeting Revised Atlanta Criteria for diagnosis of acute pancreatitis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who meet all inclusion and no exclusion criteria will be considered for enrollment. Patients presenting to the hospital or emergency room with acute pancreatitis (AP) will be screened and enrolled within 36 hours of presentation to capture relevant biomarker information as early in their episode of AP as possible. Patients with chronic calcific pancreatitis, severe systemic illness confounding severity assessments or immunological outcomes, or anyone with an altered or compromised immune system will be excluded from enrollment.
Key inclusion criteria (6 listed)
- Age 18-75 years at the time of enrollment
- Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria (see definition below)
- Participant is approached by the research team within 36 hours of presentation to the hospital
- Participant fully understands and agrees to participate in all aspects of the study, including providing informed consent, completion of interviews and data forms, and collection of biospecimens
- Acute pancreatitis is defined/diagnosed using the revised Atlanta criteria, which requires the presence of at least two of the following criteria:
Key exclusion criteria (10 listed)
- Diagnosis of definite chronic pancreatitis (CP) at enrollment (see also study definitions) based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP):
- Potential participants with post-ERCP AP who are expected to be hospitalized for less than 48 hours.
- Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.
- Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment).
- Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, and Frey procedure.
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 |
|---|---|---|
| CyTOF AnalysisCyTOF laboratory testing for cytokine levels to correlate with severity of acute pancreatitis | Diagnostic test | Acute Pancreatitis |
Primary outcome
Multi-Cytokine Panel Validation
Time frame: 4 years
Validate a novel multi-cytokine panel for early prediction of severe acute pancreatitis. The panel includes IL-8, TNFa R1, HGF, Resistin and Angiopoietin-2.
Cytokine Signature Correlation
Time frame: 4 years
Correlate temporal cytokine signatures with disease severity. We will be correlating the above cytokines as well Il-6 and MCP-1.
2 secondary outcomes
Circulating Immune Cells
Time frame: 4 years
Immune Pathways
Time frame: 4 years
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Ohio State University at 5 sites in United States.
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 6 inclusion and 10 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Zoe Krebs, BA (614-685-3619, zoe.krebs@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-Cytokine Panel Validation (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.