Actively Recruiting

Age: 18Years +
All Genders
ID02206841

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

Led by Seoul National University Boramae Hospital · Updated on 2025-05-15

1000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are establishing a group of patients with non-alcoholic fatty liver disease (NAFLD) to develop markers that can predict how liver fibrosis progresses. The study focuses on collecting various clinical data and samples to better understand the changes in liver tissue and related health factors in these patients. Participants will undergo several evaluations including imaging tests like acoustic radiation force impulse elastography, supersonic shear wave elastography, and transient elastography to assess liver fibrosis. They will also have liver biopsies to analyze liver fat and fibrosis, with tissue samples stored for future research. Blood, serum, and other biological samples will be collected to study genetic and metabolic markers. Additional tests include body composition analysis, lung function tests, heart evaluations, brain imaging, endoscopy, colonoscopy, and sleep studies. During the study, patients will be regularly assessed using laboratory and radiologic methods. The main outcome measured is the grade of liver steatosis and fibrosis at baseline, with ongoing development of markers for fibrosis progression monitored every six months for up to one year. This involves detailed clinical, imaging, and laboratory evaluations to track disease changes over time.

CONDITIONS

Brief Title

Establishment of NAFLD Cohort and Development of Fibrosis Markers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed fatty liver disease
  • Patients with radiologically confirmed fatty liver disease
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • History of significant alcohol consumption
  • Viral hepatitis
  • Autoimmune hepatitis
  • Metabolic diseases such as hemochromatosis, Wilson's disease, or alpha 1-antitrypsin deficiency
  • Use of hepatotoxic medication such as amiodarone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessments

Participants undergo diagnostic tests including liver biopsy, acoustic radiation force impulse imaging, supersonic shear wave elastography, and transient elastography to evaluate liver steatosis and fibrosis. Blood samples and tissue are collected for detailed analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored with laboratory and radiologic evaluations every 6 months for up to 1 year to track progression of hepatic fibrosis.

Visits every 6 months for up to 1 year

Trial Site Locations

Total: 1 location

1

Seoul Metropolitan Government Seoul National University

Seoul, South Korea, 156-707

Actively Recruiting

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Research Team

W

Won Kim, MD,PhD

S

Saekyung Joo, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Prospective comparison among transient elastography, supersonic shear imaging, and ARFI imaging for predicting fibrosis in nonalcoholic fatty liver disease.

Myoung Seok Lee, Jeong Mo Bae, Sae Kyung Joo...

https://pubmed.ncbi.nlm.nih.gov/29176844

A sequential approach using the age-adjusted fibrosis-4 index and vibration-controlled transient elastography to detect advanced fibrosis in Korean patients with non-alcoholic fatty liver disease.

Dong Hyeon Lee, Se Un Sung, Yun Kyu Lee...

https://pubmed.ncbi.nlm.nih.gov/35005800