RECRUITING

iMmune SignAtures and Clinical outComes in AP

Description

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
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Related Conditions:

Acute Pancreatitis

Study Overview

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Study Details

Study overview

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.

iMmune SignAtures and Clinical outComes in Acute Pancreatitis: the MoSAIC Study

iMmune SignAtures and Clinical outComes in AP

Condition
Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Chicago

University of Illinois Chicago, Chicago, Illinois, United States, 60612

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Seattle

Benaroya Research Institute, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18-75 years at the time of enrollment
  • 2. Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria (see definition below)
  • 3. Participant is approached by the research team within 36 hours of presentation to the hospital
  • 4. 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
  • 1. 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):
  • 2. Potential participants with post-ERCP AP who are expected to be hospitalized for less than 48 hours.
  • 3. Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.
  • 4. 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).
  • 5. Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, and Frey procedure.
  • 6. 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.
  • 7. Known pregnancy at the time of enrollment.
  • 8. Incarceration.
  • 9. Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Study Record Dates

2027-12-31