Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-31 @ 5:06 PM
Study NCT ID:
NCT03282305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2018-02-06
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese
Sponsor:
Great China Fatty Liver Consortium Limited
Organization:
Study Overview
Official Title:
Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH) in Chinese
Status:
NOT_YET_RECRUITING
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: