Establishment of NAFLD Cohort and Development of Fibrosis Markers (NAFLD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02206841 |
Recruitment Status :
Recruiting
First Posted : August 1, 2014
Last Update Posted : November 21, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Fibrosis of Liver | Procedure: Liver biopsy Device: ARFI Device: SWE Device: Transient elastography |
- 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 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 : | January 1, 2014 |
Estimated Primary Completion Date : | December 31, 2029 |
Estimated Study Completion Date : | December 31, 2030 |
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. |
- histologic steatosis and fibrosis grade [ Time Frame: baseline ]We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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)
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
Contact: Won Kim, MD,PhD | 8228702233 | drwon1@snu.ac.kr | |
Contact: Saekyung Joo, MD | 821089619285 | joo.sammy@gmail.com |
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 |
Principal Investigator: | Won Kim, Professor | SMG-SNU Boramae Medical Center |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | November 21, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
fibrosis markers |
Fibrosis Pathologic Processes |