Longitudinal Observational Study Of Chinese With NAFLD/NASH
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|ClinicalTrials.gov Identifier: NCT03151473|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
|Condition or disease|
|Non-Alcoholic Fatty Liver Disease (NAFLD) Non-Alcoholic Steatohepatitis (NASH)|
Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.
This study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications in Chinese subjects.
|Study Type :||Observational|
|Estimated Enrollment :||20000 participants|
|Official Title:||Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||May 31, 2027|
|Estimated Study Completion Date :||September 30, 2027|
- Prevalence of NAFL/NASH in Chinese [ Time Frame: up to 10 years ]Determine the prevalence of NAFLD/NASH in military beneficiaries ages 18 or above. This will be determined by the % of subjects determined to have NAFLD/NASH in Chinese subjects.
- Live imaging analysis [ Time Frame: up to 10 years ]Transient elastography (FibroScan) and/or MR elastography will provide a measurement of liver stiffness. The liver stiffness metrics will be tabulated for each of the three time points and assessed for change.
- Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese [ Time Frame: up to 10 years ]Cytokeratin-18 (CK-18), fibrosis-4 (FIB-4), leptin, adiponectin, TNF-alpha, PAI-1, IL-6, MCP-1, retinoids and other potential biomarkers will be determined and analysed.
- Liver histology analysis [ Time Frame: up to 10 years ]Liver histology (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up) will be examined and scored.
Biospecimen Retention: Samples Without 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): NCT03151473
|Contact: Yudong Wang, PhD||(852)firstname.lastname@example.org|
|Humanity and Health Medical Centre||Recruiting|
|Hong Kong, Hong Kong, 00852|
|Contact: George Lau, MD (852)28613777 email@example.com|
|Principal Investigator: George Lau, MD|