Actively Recruiting
iMmune SignAtures and Clinical outComes in Acute Pancreatitis: the MoSAIC Study
Led by Ohio State University · Updated on 2025-08-22
198
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying acute pancreatitis (AP) to develop an early prediction tool for severe acute pancreatitis (SAP) and to define a unique immune profile that differentiates SAP from moderate acute pancreatitis (MAP). This observational study aims to validate a multi-cytokine panel for early SAP prediction and identify specific immune cells linked to cytokine patterns, helping to understand the immune pathways driving SAP development. Participants diagnosed with acute pancreatitis based on the revised Atlanta criteria will provide blood samples and complete surveys and interviews at three time points: within 36 hours of hospital arrival, at 48 hours, and on hospital day 7 if admitted. Blood samples will be analyzed using CyTOF laboratory testing to measure cytokine levels and correlate these with disease severity. Samples will be stored and may be used for future research. The study includes data collection from electronic health records over five years and involves multiple academic sites with a centralized biospecimen coordinating center. Participants will undergo serial clinical laboratory testing, complete questionnaires, and provide biospecimens during their hospital stay. Researchers will collect data on hospital stay, medical history, clinical course, and disease severity. The primary outcomes focus on validating a multi-cytokine panel and correlating cytokine signatures over four years. Secondary outcomes include studying circulating immune cells and immune pathways. Participants' health records will be accessed for five years post-enrollment, and blood samples will be stored up to 15 years for ongoing and future analysis.
CONDITIONS
Brief Title
iMmune SignAtures and Clinical outComes in AP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at enrollment
- Diagnosis of acute pancreatitis using the revised Atlanta criteria
- Approached by research team within 36 hours of hospital presentation
- Ability to understand and agree to all study procedures including consent, interviews, and biospecimen collection
- Participation in the Immune-Mediated Diseases Registry and Repository (IMDRR)
You will not qualify if you...
- Diagnosis of definite chronic pancreatitis based on CT or MRI findings
- Post-ERCP acute pancreatitis with expected hospital stay less than 48 hours
- Presence of pancreatic tumors or cystic tumors causing pancreatitis
- Prior pancreatic surgery such as distal pancreatectomy or pancreatic necrosectomy
- Severe systemic illness that may affect outcomes or increase risk, including recent cancer treatment, transplant history, severe kidney disease, or cirrhosis
- Known pregnancy at enrollment
- Incarceration
- Any condition compromising safety or study integrity as judged by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of acute pancreatitis hospitalization
Participants undergo clinical laboratory testing and biospecimen collection during their hospitalization for acute pancreatitis.
Multiple visits during hospitalization for biospecimen collection and testing
Duration - 5 years from enrollment
Participants' electronic health records are accessed for ongoing observation of clinical outcomes and immune responses over 5 years.
No in-person visits; remote data access and assessments
Trial Site Locations
Total: 5 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Not Yet Recruiting
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Not Yet Recruiting
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
5
Benaroya Research Institute
Seattle, Washington, United States, 98101
Not Yet Recruiting
Research Team
Z
Zoe Krebs, BA
S
Samantha Terhorst, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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