Development of a Novel Biomarker for Liver Fibrosis
Completed
Conditions studied: Liver Fibrosis
In brief
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.
Key facts
- Study ID
- NCT02348814
- Run by
- University of California, Los Angeles
- People needed
- 25
- Starts
- 2015-05-01
- Expected to finish
- 2019-02-26
- Last updated by the study team
- 2019-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >/= 18 years
- At least one liver function test abnormality (AST/SGOT, ALT/SOT, alkaline phosphatase, or bilirubin) defined as a value outside of the normal range at UCLA clinical labs. This must be present on at least two occasions within a 24 month consecutive period
- Any body mass index > 20
- One of the following:
- Clinical indication, according to standard of care assessment, for undergoing image-guided percutaneous (or transjugular) liver biopsy
- Eligible for weight loss (bariatric) surgery with fatty liver disease
- NAFLD/NASH patient who meets the above criteria and has already undergone a liver biopsy for diagnosis and disease staging
- NAFLD/NASH patient who meets above criteria but chooses not to participate in the liver biopsy, extra blood draws or the dietary assessment for the study.
You may not qualify if…
- Age < 18 years
- Current pregnancy
- Significant clinical co-morbidities that would preclude getting either a percutaneous or transjugular liver biopsy (i.e. platelets < 50, 000 or International Normalized Ratio (INR) > 1.5 or Hemoglobin < 8)
- Unwilling or unable to participate or consent.
Where it is running
- UCLA Clinical and Translational Research Center (CTRC) — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.