iMmune SignAtures and Clinical outComes in AP

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

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 design

Treatments tested in this trial

  • CyTOF Analysis

Treatment groups

198 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ohio State University

Lead sponsor

University of Pittsburgh

Collaborator

University of Illinois at Chicago

Collaborator

University of Southern California

Collaborator

Benaroya Research Institute

Collaborator