RECRUITING

iMmune SignAtures and Clinical outComes in AP

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Conditions

Acute PancreatitisImmunologyMoSAIC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-06
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05878236

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-75 years at the time of enrollment
  2. 2. Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria (see definition below)
  3. 3. Participant is approached by the research team within 36 hours of presentation to the hospital
  4. 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. 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. 2. Potential participants with post-ERCP AP who are expected to be hospitalized for less than 48 hours.
  3. 3. Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.
  4. 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. 5. Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, and Frey procedure.
  6. 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. 7. Known pregnancy at the time of enrollment.
  8. 8. Incarceration.
  9. 9. Any other condition or factor that would compromise the participant's safety or the scientific integrity of the study.

Contacts and Locations

Study Contact

Zoe Krebs, BA
CONTACT
614-685-3619
zoe.krebs@osumc.edu
Samantha Terhorst, MS
CONTACT
614-685-3618
samantha.terhorst@osumc.edu

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
The Ohio State University
Columbus, Ohio, 43210
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Benaroya Research Institute
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-03-06
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Acute Pancreatitis
  • Immunology
  • MoSAIC

Additional Relevant MeSH Terms

  • Acute Pancreatitis