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iMmune SignAtures and Clinical outComes in AP

ConditionAcute Pancreatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CyTOF Analysis

    Diagnostic test

    CyTOF laboratory testing for cytokine levels to correlate with severity of acute pancreatitis

Treatment groups

198 Participants
are divided into 1 treatment group
Group A: Acute Pancreatitis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 years
2

Cytokine Signature Correlation

Correlate temporal cytokine signatures with disease severity. We will be correlating the above cytokines as well Il-6 and MCP-1.

Time frame
4 years

Secondary outcomes

1

Circulating Immune Cells

Identify circulating immune cells that correspond with cytokine signatures in early acute pancreatitis

Time frame
4 years
2

Immune Pathways

Characterize the immune pathways driving the development of severe acute pancreatitis

Time frame
4 years

Other outcomes

Sponsors and contacts

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Ohio State University

Lead sponsor

University of Pittsburgh

Collaborator

University of Illinois at Chicago

Collaborator

University of Southern California

Collaborator

Benaroya Research Institute

Collaborator

Source ClinicalTrials.gov
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