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Liquid Biopsy for NASH and Liver Fibrosis

NCT04677101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-05-19

No results posted yet for this study

Summary

Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression.

Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity.

Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings.

Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • Liver Fibroses

Interventions

DIAGNOSTIC_TEST

Liver Biopsy

Fine-needle liver biopsy

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2021-03-16
Completion
2021-04-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677101 on ClinicalTrials.gov