iMmune SignAtures and Clinical outComes in AP — MoSAIC  

Acute Pancreatitis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

All participants will sign an informed consent before participating in the study. Adult subjects of both sexes and belonging to all ethnicities will be enrolled. Participants will consent for access to their electronic health records, complete study questionnaires, undergo serial clinical laboratory testing and provide biospecimens during their acute pancreatitis (AP) hospitalization. The research team will access the electronic health records for 5 years from the time of enrollment in the study.

The study network is comprised of five academic sites. Four sites will enroll AP patients [OSU, University of Illinois in Chicago Hospital (UIC), University of Pittsburgh Medical Center (UPMC), and the Keck Hospital of the University of Southern California (USC)]. The fifth site, the Benaroya Research Institute (BRI) will coordinate biospecimen handling for analyses, perform bioinformatics and serve as the biospecimen coordinating center (BCC). Each enrolling site will collect and ship biosamples to BRI. The blood samples collected in this study will be deposited into the Benaroya Research Institute (BRI) Immune-Mediated Diseases Registry and Repository (IMDRR). Participation in the repository is a requirement for inclusion in the study. Specimens collected in this study will be used for immune assays. Samples will also be coded and stored for up to 15 years in the IMDRR. Samples may be used to evaluate additional responses as new research tools become available or exploratory hypotheses are generated. OSU will serve as the data coordinating center (DCC). Coordinators at enrolling sites will enter study data into a secure cloud-based electronic database, and the DCC will be in charge of monitoring the quality and completeness of the electronic data. ;

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

• NCT number: NCT05878236
• Study type: Observational
• Source: Ohio State University
• Contact: Zoe Krebs, BA
• Phone: 614-685-3619
• Email: zoe.krebs@osumc.edu
• Status: Recruiting
• Start date: March 6, 2023
• Completion date: December 31, 2027