Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT05878236

iMmune SignAtures and Clinical outComes in AP

Led by Ohio State University · Updated on 2025-08-22

198

Participants Needed

5

Research Sites

251 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

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

Official Title

iMmune SignAtures and Clinical outComes in AP

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years at the time of enrollment
  • Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria
  • Participant is approached by the research team within 36 hours of hospital presentation
  • Participant fully understands and agrees to participate in all study aspects, including informed consent, interviews, data forms, and biospecimen collection
Not Eligible

You will not qualify if you...

  • Definite chronic pancreatitis at enrollment confirmed by CT, MRI, or MRCP imaging
  • Post-ERCP acute pancreatitis expected to require less than 48 hours hospitalization
  • Pancreatic tumors including ductal adenocarcinoma, neuroendocrine tumors, and metastasis
  • Confirmed or suspected cystic tumor causing main pancreatic duct dilation or acute pancreatitis
  • Prior pancreatic surgery including distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, or Frey procedure
  • Severe systemic illness posing risk or confounding outcomes, including solid organ transplant history, AIDS, active cancer treatment within 12 months (except non-melanoma skin cancer), chronic kidney disease with eGFR <30 or dialysis, cirrhosis, or life expectancy less than 12 months
  • Known pregnancy at enrollment
  • Incarceration
  • Any other condition that compromises participant safety or study integrity

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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

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Research Team

Z

Zoe Krebs, BA

CONTACT

S

Samantha Terhorst, MS

CONTACT

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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