Longitudinal Observational Study Of Chinese With NAFLD/NASH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHumanity and Health Research Centre
About this trial
This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females aged 18 and older;
Adults being managed or treated for NAFL or NASH;
Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
Disqualifiers
Incompetent to understand and/or sign the informed consent;
Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female;
Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
Diagnosis of liver cirrhosis and/or hepatocellular carcinoma;
Trial population
Subjects (BMI ≥ 25 kg/m2) with proven NAFL/NASH either by imaging (using MRI) or histology, referred to secondary or tertiary care for liver related problems will be asked to participate in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of NAFL/NASH in Chinese
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.
Time frame
up to 10 yearsSecondary outcomes
1
Live imaging analysis
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.
Time frame
up to 10 years2
Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese
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.
Time frame
up to 10 years3
Liver histology analysis
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.
Time frame
up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov