Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis (InTeam)
Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis|
- Diagnosis and Severity of Alcoholic Hepatitis [ Time Frame: 3 months after end of Study ] [ Designated as safety issue: No ]Utilizing liver tissue, blood samples, and stool and urine samples, InTeam will aim to discover and validate factors associated with the diagnosis and severity of Alcoholic hepatitis.
- Major Liver Complications [ Time Frame: 3 months after end of study ] [ Designated as safety issue: No ]As an observational study, we will collect data regarding major liver complications such as, ascites, renal failure, encephalopathy, and bleeding.
- Death/Transplantation [ Time Frame: 3 months after end of study ] [ Designated as safety issue: No ]As an observational study, we will collect the data regarding number the survival of Alcoholic Hepatitis by considering deaths and transplantations.
Biospecimen Retention: Samples With DNA
Serum, Plasma, Whole Blood DNA, PBMCs, Urine, Stool, Liver Biopsy
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
The development of new targeted therapies for alcoholic hepatitis (AH) is one of the more urgent needs in clinical hepatology. To reach this goal, large multidisciplinary networks are required. The proposed initiative "Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis" (InTeam) will coordinate a multidisciplinary group composed of clinicians, physician-scientists, basic scientists and bioinformatics experts. The overarching hypothesis of InTeam is that the most rational way to provide a useful framework for future clinical trials in (AH) consists of the (i) determination of key drivers of the disease process, (ii) classification of molecular profiles and subtypes of AH, and (iii) identification of "druggable" targets based on both key drivers and molecular classification. Moreover, mouse models for AH are lacking making it impossible to evaluate promising targets in preclinical mouse studies in a meaningful manner. For this purpose, InTeam will integrate data obtained from molecular pathology studies in human AH and functional studies of key pathways in animal models. The proposed InTeam consortium includes three research projects, ten clinical centers, a Human Biorepository and a Mouse Models Core. The Human Biorepository Core will generate the to-date largest collection of samples from patients with AH from 10 academic liver centers and a comprehensive database that will serve as a basis for the proposed translational studies and be a valuable asset for the broader scientific community. The Mouse Models core will conduct murine studies after establishing and evaluating mouse models of AH based on the pathophysiology and molecular drivers of human AH determined by this consortium.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02075918
|Contact: Ramon Bataller, MD||(919) email@example.com|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Not yet recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator: Ramon Bataller, MD|
|Principal Investigator:||Ramon Bataller, MD||University of North Carolina, Chapel Hill|