Establishment of NAFLD Cohort and Development of Fibrosis Markers

Study Overview
=================
Brief Summary
-----------------
This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.

Detailed Description
-----------------
Acoustic radiation force impulse elastography and transient elastography Liver tissue (frozen tissue, paraffin block) Whole blood, Serum Fat amount ratio CT (Visceral adipose tissue, Subcutaneous adipose tissue amount) Body composition analyzer (InBody scale):Total fat/muscle mass and appendicular skeletal muscle mass Pulmonary function test with post-bronchodilator response and DLCo EKG, EchoCG, Heart CT (Coronary calcium score), and Pusle wave velocity (AI index, arterial stiffness) Brain MRI or CT Upper esophagogastroscopy and colonoscopy Berlin score questionnaire and Polysomnography

Official Title
-----------------
Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis

Conditions
-----------------
Fibrosis of Liver

Intervention / Treatment
-----------------
* Procedure: Liver biopsy
* Device: ARFI
* Device: SWE
* Device: Transient elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed fatty liver disease Patients with radiologically confirmed fatty liver disease Exclusion Criteria: History of significant alcohol consumption Viral hepatitis Autoimmune hepatitis Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency) Hepatotoxic medication (e.g. amiodarone)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD<br>Patients with suspected nonalcoholic fatty liver disease will be screened. Of all patients fulfilling inclusion criteria, baseline characteristics will be obtained. In addition, laboratory, radiologic evaluations such as ARFI, SWE, and transient elastography will be performed. A diagnostic liver biopsy will be performed for analysis of steatosis and fibrosis. Parts of the remaining liver tissue will be stored by frozen tissue and paraffin block for future study. Several serum and plasma samples are collected of patients and stored for future analysis such as targeted SNP arrays, super-enhancer RNA (eRNA) expression, whole exome sequencing, RNA chip sequencing, RNA microarray, genomic DNA, metabolomics, fecal microbiome, metabolite, metagenome/metatranscriptome analyses. | Procedure: Liver biopsy<br>* Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.<br>Device: ARFI<br>* Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.<br>Device: SWE<br>* Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.<br>Device: Transient elastography<br>* Transient elastography will be performed for evaluate fibrosis of liver.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic steatosis and fibrosis grade | We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of markers for hepatic fibrosis progression | We will analysis and development fibrosis markers by obtained blood sample and liver tissue, | baseline and every 6 months (up to 1year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrosis, markers