Integrated Approaches for Identifying Molecular Targets in Liver Disease (InLi)
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|ClinicalTrials.gov Identifier: NCT03915002|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 5, 2020
To provide a framework for successful clinical trials testing novel targets for therapy in liver disease.
To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression.
Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.
|Condition or disease|
|Alcoholic Liver Disease Non-Alcoholic Fatty Liver Disease Steatohepatitis, Nonalcoholic Steatohepatitis|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Integrated Approaches for Identifying Molecular Targets in Liver Disease|
|Actual Study Start Date :||June 13, 2019|
|Estimated Primary Completion Date :||April 15, 2022|
|Estimated Study Completion Date :||April 15, 2030|
Patients 18 years or older with a diagnosis of cholestatic liver diseases (primary biliary cholangitis or primary sclerosing cholangitis) or hepatotropic virus (hepatitis C or B virus), according to the current international guidelines.
Patients over 18 years old without a diagnosis of liver disease that for any other reason (i.e candidate to liver donor, patients with liver metastasis that require surgery, patients with any type of benign liver tumor or HCC in a healthy liver).
Patient over 18 years old with a documented alcoholic used disorder in their clinical records and without any evidence of liver disease.
- Molecular Subtypes for Targeted Therapies in Liver disease [ Time Frame: 5 years ]
- Generation of consistent non-invasive molecular footprints of disease severity and prognosis: plasma and peripheral blood cells from groups of patients with different disease prognosis will be analyzed by means of high throughput proteomics (Mass Spectrometry and aptamer mediated identification) and single cell RNA sequencing, respectively. Data will be integrated with liver RNA-sequencing to detect relevant liver fingerprints in plasma.
- Mechanisms of ductular reaction and hepatocyte de-differentiation will be studied by micro-dissection and region-specific RNA-sequencing.
- Mechanisms of hepatocyte dedifferentiation will be evaluated using methylation bead chip and chromatin immunoprecipitation coupled to DNA sequencing (ChIP-seq) of histone marks related with activation, enhancement, poisoning and repression of gene expression.
- Determination of key drivers of the disease progression [ Time Frame: 5-10 years ]
- To describe and identified the histological patters in each phase of the disease (using imaging technics, including second harmonic generation imaging microscopy and electronic microscopy as well as classical IHC technics)
- To quantified and compare the degree of hepatic steatosis and fibrosis assessed by non-invasive techniques such as FibroScan® (CAP controlled attenuation parameter) across different cohorts of patients and across the different stages of the disease within the same patient's phenotype.
- To identify the main genetic. psychosocial, and environmental factors influencing the development of advanced liver fibrosis among patients with known or suspected excessive alcohol intake. Through DNA
- repository capable of providing a framework fro the other outcomes [ Time Frame: 2-10 years ]To develop a bio-specimen bank comprised of plasma, DNA, and other biological specimens obtained from patients with alcoholic hepatitis, control disease and healthy controls
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915002
|United States, Pennsylvania|
|University of Pittsburgh Medical center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Ramon Bataller, MD, PhD 412-383-4241 firstname.lastname@example.org|