Development of a Novel Biomarker for Liver Fibrosis

Liver Fibrosis Clinical Trial

Official title: Development of a Novel Biomarker for Liver Fibrosis

Status Completed

Clinical Trial Summary

The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients.

Clinical Trial Description

Preliminary data suggest that cholesterol and retinoid metabolism are tightly linked in these cells, prompting us to examine this relationship in the setting of obesity and diabetes. Specific aims have been developed to test the following hypotheses: 1) Quantifying liver fibrosis as a continuous variable will predict clinically significant outcomes in fatty liver disease related to metabolic syndrome; and 2) In a prospective cohort of patients, quantified liver fibrosis will correlate more strongly with tissue and circulating retinoid metabolites than with other, commonly measured serum markers.

This study offers a major innovation by performing accurate fibrosis quantification without any human intervention or post-analysis correction. In addition, we can test whether subtle differences in quantified fibrosis impact outcome for a given clinical stage of disease severity, possible because we are measuring fibrosis as a continuous variable, not a categorical one. We are using a disease-independent approach to evaluate anti-fibrotic agents in clinical trials and for evaluating other diagnostic markers.

We are also testing whether a novel diagnostic marker, retinoid storage, correlates with liver disease progression in humans. We propose to extend the study to address fatty liver disease, NAFLD/NASH, in the context of adult patients with abnormal liver tests, fatty liver identified on imaging, physical obesity, and diabetes. Clinical variables and outcomes to be recorded and analyzed include: morphology (age, gender, ethnicity, height, weight/BMI, waist circumference and steatosis on imaging studies); biochemistry (glucose intolerance or diabetes, complete blood counts, metabolic panels, liver function tests, cholesterol panels, insulin, and vitamin D levels); clinical outcomes (date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer, and death); medications (current or previous prescribed, herbals, supplements taken for diabetes, dyslipidemia, hypertension, cardiovascular disease, or stroke); and disease exacerbation/modifying factors (presence of other chronic liver diseases such as NASH + HIV, liver toxins such as alcohol consumption, weight gain, or worsening diabetes).

Data will be collected from subjects who complete eight visits over a 24-month period. Assessments will include morphometric measurements, blood collection for laboratory analysis and completion of dietary history report. ;

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

• NCT number: NCT02348814
• Study type: Observational
• Source: University of California, Los Angeles
• Status: Completed
• Start date: May 2015
• Completion date: February 26, 2019