iMmune SignAtures and Clinical outComes in AP

NCT05878236 | Recruiting DMC

• 1 other identifier: 2022H0394
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 5

Brief 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). 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.

Conditions

Acute Pancreatitis

Keywords

Acute Pancreatitis; Immunology; MoSAIC

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 years

Secondary Outcomes (2)

• Circulating Immune Cells

  4 years

• Immune Pathways

  4 years

Study Arms (1)

Acute Pancreatitis

Patients meeting Revised Atlanta Criteria for diagnosis of acute pancreatitis

Diagnostic Test: CyTOF Analysis

Interventions

CyTOF Analysis DIAGNOSTIC_TEST

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

Acute Pancreatitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• i. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ohio State University: lead
• University of Pittsburgh: collaborator
• University of Illinois at Chicago: collaborator
• University of Southern California: collaborator
• Benaroya Research Institute: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

NOT YET RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Benaroya Research Institute

Seattle, Washington, 98101, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buffy Coat from Plasma samples will be collected and stored for genetic analysis.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Zoe Krebs, BA

CONTACT

614-685-3619; zoe.krebs@osumc.edu

Samantha Terhorst, MS

CONTACT

614-685-3618; samantha.terhorst@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine, Director of Gastroenterology

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 26, 2023
• Study Start: March 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (5)