Establishment of NAFLD Cohort and Development of Fibrosis Markers

Recruiting

• Conditions: Fibrosis of Liver
• Interventions: Procedure: Liver biopsy; Device: ARFI; Device: SWE; Device: Transient elastography

• Registration Number: NCT02206841
• Lead Sponsor: Seoul National University Boramae Hospital

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

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD	SWE	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.
NAFLD	Liver biopsy	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.
NAFLD	Transient elastography	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.
NAFLD	ARFI	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.

Primary Outcome Measures

Name	Time	Method
histologic steatosis and fibrosis grade	baseline	We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

Secondary Outcome Measures

Name	Time	Method
Development of markers for hepatic fibrosis progression	baseline and every 6 months (up to 1year)	We will analysis and development fibrosis markers by obtained blood sample and liver tissue,

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University; 🇰🇷 Seoul, Korea, Republic of