This study is currently not recruiting participants.

Evaluation of the Significance of Cell Free DNA Epigenetic Markers as Predicative Factors for Nonalcoholic Fatty Liver Disease (NAFLD)

Study on Identifying Stages of Nonalcoholic Steatohepatitis (NASH) Using Blood Samples

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The specific aims of this study are to provide a source of whole blood samples from subjects diagnosed with NASH (nonalcoholic steatohepatitis) to:

Test the hypothesis that absence of NAFL (nonalcoholic fatty liver) can be distinguished from early stage NAFLD (nonalcoholic fatty liver disease) and NASH w/o and NASH w/ fibrosis groups using cfDNA Cell free DNA) and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Test the hypothesis that early stage NAFLD can be distinguished from NASH w/o and NASH w/ fibrosis groups using cfDNA and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Test the hypothesis that NASH w/o fibrosis can be distinguished from NASH w/ fibrosis group using cfDNA and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Detailed description of study

The specific aims of this study are to provide a source of whole blood samples from subjects diagnosed with NASH (nonalcoholic steatohepatitis) to:

Test the hypothesis that absence of NAFL (nonalcoholic fatty liver) can be distinguished from early stage NAFLD (nonalcoholic fatty liver disease) and NASH w/o and NASH w/ fibrosis groups using cfDNA Cell free DNA) and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Test the hypothesis that early stage NAFLD can be distinguished from NASH w/o and NASH w/ fibrosis groups using cfDNA and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Test the hypothesis that NASH w/o fibrosis can be distinguished from NASH w/ fibrosis group using cfDNA and/or epigenetic markers such as elevated liver fraction, hepatic stellate cell activation, novel plasma methylation patterns or a combination thereof.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonalcoholic Fatty Liver Disease
  • Age: 100 years or below
  • Gender: All

This study investigates nonalcoholic steatohepatitis (NASH), a liver condition, by collecting whole blood samples. The purpose is to distinguish between different stages of liver disease, such as the absence of nonalcoholic fatty liver (NAFL) and early-stage nonalcoholic fatty liver disease (NAFLD), using markers found in cell-free DNA (cfDNA) and other epigenetic indicators. These markers may include elevated liver fraction and hepatic stellate cell activation, which are changes in the liver that can be detected in the blood.

Participants in the study will have their blood tested for specific patterns, like plasma methylation, which is a chemical change in the DNA that can indicate liver disease. The study aims to see if these blood tests can tell apart various stages of liver disease, including NASH with or without fibrosis, which is a type of liver scarring.

  • Who can participate: The eligibility criteria for this study are not specified in the provided information.
  • Study details: Participants will provide whole blood samples for testing. The study will analyze these samples for cell-free DNA and epigenetic markers to identify different stages of liver disease. A placebo is not involved in this study.
Updated on 19 Feb 2024. Study ID: 1710687227

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