Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese
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|ClinicalTrials.gov Identifier: NCT03282305|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : February 6, 2018
Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple steatosis to cirrhosis of the liver. Nonalcoholic fatty liver (NAFL) without substantial hepatocellular injury is thought to be relatively benign whereas nonalcoholic steatohepatitis (NASH) is characterized by hepatocyte steatosis, ballooning, inflammation and varying degrees of fibrosis from none to cirrhosis. NASH is strongly associated with insulin resistance and metabolic syndrome and thus is recognized as a major public health concern as the most prevalent liver disease.
Liver biopsy is the gold standard for a diagnosis of NASH. However, given the large population of patients at risk for NASH, liver biopsy is not a practical method for determining which patients may benefit from NASH therapy. Non-invasive methods to estimate inflammation and fibrosis are in clinical use, but there remains a dichotomy between gold standard inclusion criteria and end points that are utilized in clinical trials and real world diagnostic methods that are more common in clinical practice.
Thus, the investigators would like to conduct an observational study to head-to-head compare the non-invasive methods and liver biopsy in differential liver steatosis and liver biopsy in a real-world setting. Also, by following up patients for a relatively long time (proposed 10 years), the investigators can present the natural history of disease progression.
|Condition or disease|
|Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis|
GC-FLC is a cooperative consortium of principal investigators from academic institutions and community-based sites treating patients with NAFLD and NASH. The investigators will leverage the multidisciplinary expertise within this network in bio-banking, high-throughput technologies, and biomedical informatics to give investigators the power to analyze effectiveness data at many different levels of resolution, ranging from subsets of patients to very large populations.
GC-FLC will use standardized data collection practices, study data monitoring, and an comprehensive observational protocol in order to increase the efficiency and minimize costs associated with performing clinical research while ensuring collection of detailed critical safety and effectiveness data on prescribed NASH therapies. GC-FLC engages community and academic practice providers as partners in the research to ensure rapid translation of research findings into improvement in healthcare quality and outcomes and to help engage scientists at the interfaces between clinical research and the community. Furthermore, GC-FLC provides the opportunity to pair-comparison between liver biopsy and non-invasive biomarkers in differential low-risk and high-risk population for treatment in real world settings.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH) in Chinese|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||December 2028|
|Estimated Study Completion Date :||December 2029|
- Histological endpoint [ Time Frame: 10 years ]The change in NASH Clinical Research Network (CRN) score based on liver biopsy
- Number of all-cause death [ Time Frame: 10 years ]Number of all-cause death
- Number of liver-related death [ Time Frame: 10 years ]Number of liver-related death
- Number of liver transplant [ Time Frame: 10 years ]Number of liver transplant
- Number of hepatocellular carcinoma (HCC) [ Time Frame: 10 years ]Number of hepatocellular carcinoma (HCC)
Biospecimen Retention: Samples With DNA
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): NCT03282305
|Contact: Jing Chen, Ph.D.||email@example.com|
|Contact: Danny Wang, PhD.||firstname.lastname@example.org|
|Principal Investigator:||Vincent Wong, MD, PhD||Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.|
|Study Chair:||George Lau, MD, PhD||Division of Gastroenterology & Hepatology, Humanity & Health Medical Centre, Hong Kong SAR, China.|
|Study Director:||Arun Sanyal, MD, PhD||Physiology and Molecular Pathology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA|