AzTrials
AzTrials

Fibrosis of LiverNAFLDNCT02206841

Establishment of NAFLD Cohort and Development of Fibrosis Markers

An observational study of Fibrosis of Liver, run by Seoul National University Boramae Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibrosis of Liver
What is being tested?
Liver biopsy, ARFI and SWE
How many people
1,000 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2014to 31 Dec 2030
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Non-alcoholic fatty liver disease

Who may be able to join

  • Patients with histologically confirmed fatty liver disease
  • Patients with radiologically confirmed fatty liver disease

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Won Kim, MD,PhD contact

8228702233

drwon1@snu.ac.kr

Saekyung Joo, MD contact

821089619285

joo.sammy@gmail.com

South Korea1 site, 1 recruiting

  • Seoul Metropolitan Government Seoul National University

    Seoul, 156-707

    Won Kim, MD, PhD, 8228702233, drwon1@snu.ac.kr

    Won Kim, MD,PhD

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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
Being tested
Liver biopsy, ARFI, SWE, Transient elastography
Keywords
fibrosis, markers
Medical subject headings
Liver Cirrhosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver biopsyProcedure or surgery

    Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.

  • ARFIDevice

    Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.

  • SWEDevice

    Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.

  • Transient elastographyDevice

    Transient elastography will be performed for evaluate fibrosis of liver.

Study groups in NCT02206841
Study groupRoleWhat they receive
NAFLDPatients 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.
Receives: Procedure: Liver biopsy; Device: ARFI; Device: SWE; Device: Transient elastography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. histologic steatosis and fibrosis grade

    We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

    Measured: baseline

Secondary outcomes (1)

  1. Development of markers for hepatic fibrosis progression

    We will analysis and development fibrosis markers by obtained blood sample and liver tissue,

    Measured: baseline and every 6 months (up to 1year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study start1 Jan 2014
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02206841
Sponsor's protocol ID
NAFLD_cohort
Acronym
NAFLD
Status last verified
May 2025
First submitted
28 Jul 2014
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Koo BK, Joo SK, Kim D, Bae JM, Park JH, Kim JH, Kim W. Additive effects of PNPLA3 and TM6SF2 on the histological severity of non-alcoholic fatty liver disease. J Gastroenterol Hepatol. 2018 Jun;33(6):1277-1285. doi: 10.1111/jgh.14056. Epub 2018 Feb 26.

    PubMed 29193269

  • Koo BK, Um SH, Seo DS, Joo SK, Bae JM, Park JH, Chang MS, Kim JH, Lee J, Jeong WI, Kim W. Growth differentiation factor 15 predicts advanced fibrosis in biopsy-proven non-alcoholic fatty liver disease. Liver Int. 2018 Apr;38(4):695-705. doi: 10.1111/liv.13587. Epub 2017 Sep 30.

    PubMed 28898507

  • Joo SK, Kim W, Kim D, Kim JH, Oh S, Lee KL, Chang MS, Jung YJ, So YH, Lee MS, Bae JM, Kim BG. Steatosis severity affects the diagnostic performances of noninvasive fibrosis tests in nonalcoholic fatty liver disease. Liver Int. 2018 Feb;38(2):331-341. doi: 10.1111/liv.13549. Epub 2017 Sep 5.

    PubMed 28796410

  • Kim D, Kim W, Joo SK, Bae JM, Kim JH, Ahmed A. Subclinical Hypothyroidism and Low-Normal Thyroid Function Are Associated With Nonalcoholic Steatohepatitis and Fibrosis. Clin Gastroenterol Hepatol. 2018 Jan;16(1):123-131.e1. doi: 10.1016/j.cgh.2017.08.014. Epub 2017 Aug 18.

    PubMed 28823829

  • Kim JY, Park KJ, Hwang JY, Kim GH, Lee D, Lee YJ, Song EH, Yoo MG, Kim BJ, Suh YH, Roh GS, Gao B, Kim W, Kim WH. Activating transcription factor 3 is a target molecule linking hepatic steatosis to impaired glucose homeostasis. J Hepatol. 2017 Aug;67(2):349-359. doi: 10.1016/j.jhep.2017.03.023. Epub 2017 Mar 30.

    PubMed 28365312

  • Koo BK, Kim D, Joo SK, Kim JH, Chang MS, Kim BG, Lee KL, Kim W. Sarcopenia is an independent risk factor for non-alcoholic steatohepatitis and significant fibrosis. J Hepatol. 2017 Jan;66(1):123-131. doi: 10.1016/j.jhep.2016.08.019. Epub 2016 Sep 4.

    PubMed 27599824

  • Lee MS, Bae JM, Joo SK, Woo H, Lee DH, Jung YJ, Kim BG, Lee KL, Kim W. Prospective comparison among transient elastography, supersonic shear imaging, and ARFI imaging for predicting fibrosis in nonalcoholic fatty liver disease. PLoS One. 2017 Nov 27;12(11):e0188321. doi: 10.1371/journal.pone.0188321. eCollection 2017.

    PubMed 29176844

  • Lee DH, Sung SU, Lee YK, Lim IH, Jang H, Joo SK, Park JH, Chang MS, So YH, Kim W; Innovative Target Exploration of NAFLD (ITEN) Consortium. 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. Aliment Pharmacol Ther. 2022 Apr;55(8):994-1007. doi: 10.1111/apt.16766. Epub 2022 Jan 9.

    PubMed 35005800

  • Kim D, Kim W, Joo SK, Han J, Kim JH, Harrison SA, Younossi ZM, Ahmed A. Association between body size-metabolic phenotype and nonalcoholic steatohepatitis and significant fibrosis. J Gastroenterol. 2020 Mar;55(3):330-341. doi: 10.1007/s00535-019-01628-z. Epub 2019 Sep 18.

    PubMed 31535207

  • Kim D, Kim W, Joo SK, Kim JH, Harrison SA, Younossi ZM, Ahmed A. Predictors of nonalcoholic steatohepatitis and significant fibrosis in non-obese nonalcoholic fatty liver disease. Liver Int. 2019 Feb;39(2):332-341. doi: 10.1111/liv.13983. Epub 2018 Oct 27.

    PubMed 30298568

Questions about this trial

What is this clinical trial studying?

An observational study of Fibrosis of Liver, run by Seoul National University Boramae Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Won Kim, MD,PhD (8228702233, drwon1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

histologic steatosis and fibrosis grade (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206841, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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