Identifying immune profiles in acute pancreatitis

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

This study is trying to see if analyzing immune responses in blood samples can help predict severe cases of acute pancreatitis in people shortly after they are admitted to the hospital.

Quick facts

• Study type: Observational
• Enrollment: 198 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT05878236 on ClinicalTrials.gov

What this trial studies

The MoSAIC study is a prospective, observational initiative aimed at developing an early prediction tool for severe acute pancreatitis (SAP) by analyzing immune responses. It seeks to validate a multi-cytokine panel for predicting SAP and to identify immune cells associated with cytokine signatures during early acute pancreatitis. Participants will provide blood samples and complete surveys within 36 hours of hospital admission, with follow-ups at 48 hours and on hospital day 7. Data on clinical outcomes, medical history, and disease severity will be collected to enhance understanding of immune pathways in acute pancreatitis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with acute pancreatitis within 36 hours of hospital presentation.

Not a fit: Patients with chronic pancreatitis or those diagnosed outside the specified time frame may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early prediction and management of severe acute pancreatitis, potentially reducing complications and hospital stays.

How similar studies have performed: Other studies have shown promise in using immune profiling for predicting outcomes in acute pancreatitis, suggesting potential for success in this approach.

Eligibility criteria

Inclusion 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

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.

Exclusion Criteria:

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):

   i. Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular) ii. Intraductal filling defects suggestive of calcifications on MRI and/or MRCP iii. Non-contrast imaging is acceptable for the assessment of definite CP, but calcifications noted by endoscopic ultrasound only (and not correlated with CT) are not considered definite CP. Patients with autoimmune pancreatitis, but no evidence of calcifications, may still be enrolled, assuming they satisfy inclusion criteria for 'diagnosis of AP'
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.

Where this trial is running

Los Angeles, California and 4 other locations

• University of Southern California — Los Angeles, California, United States (Not_yet_recruiting)
• University of Illinois Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• Benaroya Research Institute — Seattle, Washington, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Zoe Krebs, BA

Conditions Acute Pancreatitis; Immunology; MoSAIC