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NCT02438917 · ClinicalTrials.gov registry record
Biomarkers of Liver Fibrosis
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- 10
- Enrollment target
NCT02438917: Clinical Trial study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02438917 is a clinical trial that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438917 was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
Chronic liver injury leads to the accumulation of proteins in the liver that form dense scars. Liver scar formation is typically a slow process that leads to major organ damage and loss of function over the course of many years. During scar formation the extracellular matrix in the liver changes. The type and quantity of extracellular collagen and other proteins change during tissue remodeling. Some of these changes can be detected by analyzing factors present in blood. Because of the lengthy time course, changes in the rate of liver scar formation and regression are very difficult measure; however, accurate measurements are needed in order to conduct trials of interventions aimed at preventing scar formation and/or promotion scar regression. Current methods have sub-optimal specificity and selectivity. The long term objective of the study is to identify serum proteins that can be used to accurately estimate rates of liver fibrosis progression and regression. The project focusses on a novel methodology that uses stable isotope labeling with deuterated water, D2O, to tag newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. This ratio provides information about the rate of synthesis of the protein of interest. This method will be applied to specimens from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment. Treatment is known to reduce liver inflammation and collagen content.
Primary Outcome
Change in the ratio of transforming growth factor binding protein 1 (TGFB1) at 36 months as compared to baseline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-03-03 |
Why NCT02438917 stopped before completion
NCT02438917 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02438917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02438917 about?
NCT02438917 is a clinical study titled "Biomarkers of Liver Fibrosis". Chronic liver injury leads to the accumulation of proteins in the liver that form dense scars. Liver scar formation is typically a slow process that leads to major organ damage and loss of function over the course of many years. During scar formation the extracellular matrix in the liver changes. Th...
What is the current status of trial NCT02438917?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2015-06. Estimated completion is 2017-03-03.
Who is sponsoring clinical trial NCT02438917?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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