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Establishment of NAFLD Cohort and Development of Fibrosis Markers (NAFLD)

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ClinicalTrials.gov Identifier: NCT02206841
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Won Kim, 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.

Condition or disease Intervention/treatment
Fibrosis of Liver Procedure: Liver biopsy Device: ARFI Device: SWE Device: Transient elastography

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
Study Start Date : June 2014
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023


Group/Cohort Intervention/treatment
NAFLD
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
Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.

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

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

Device: Transient elastography
Transient elastography will be performed for evaluate fibrosis of liver.




Primary Outcome Measures :
  1. histologic steatosis and fibrosis grade [ Time Frame: baseline ]
    We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.


Secondary Outcome Measures :
  1. Development of markers for hepatic fibrosis progression [ Time Frame: baseline and every 6 months (up to 1year) ]
    We will analysis and development fibrosis markers by obtained blood sample and liver tissue,


Biospecimen Retention:   Samples With DNA
Obtained blood samples will be stored by serum and plasma for future analysis.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Non-alcoholic fatty liver disease
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)

Information from the National Library of Medicine

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): NCT02206841


Contacts
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Contact: Won Kim, MD,PhD 8228702233 drwon1@snu.ac.kr
Contact: Saekyung Joo, MD 821089619285 joo.sammy@gmail.com

Locations
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Korea, Republic of
Seoul Metropolitan Government Seoul National University Recruiting
Seoul, Korea, Republic of, 156-707
Contact: Won Kim, MD, PhD    8228702233    drwon1@snu.ac.kr   
Principal Investigator: Won Kim, MD,PhD         
Sponsors and Collaborators
Seoul National University Boramae Hospital
Investigators
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Principal Investigator: Won Kim, Professor SMG-SNU Boramae Medical Center
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Won Kim, M.D, PhD, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT02206841    
Other Study ID Numbers: NAFLD_cohort
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Won Kim, Seoul National University Boramae Hospital:
fibrosis
markers
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes