Assessing Signatures for Fibrosis Detection in Chronic Liver Disease: A Step Beyond Conventional Biomarkers

April 30, 2026 updated by: Universitair Ziekenhuis Brussel

Assessing Signatures for Fibrosis Detection in Chronic Liver Disease: A Step Beyond Conventional Biomarkers.

Morbidity and mortality of CLD is driven by the extent of liver fibrosis, characterized by scar formation and disruption of the normal liver architecture. HSCs play a central role in liver fibrosis development. When hepatocytes are damaged, HSCs undergo myofibroblast differentiation, transitioning into an activated state. So far, no efficient biomarkers can estimate the degree of HSC activation or reversal across all aetiologies of CLD, although this could be a more sensitive marker than fibrosis measurement which is secondary to HSC activation. This study aims to correlate biomarkers to the fibrosis stage in a larger cohort of patients with CLD across all aetiologies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18y
  • Chronic liver disease: alcohol, metabolic dysfunction associated steatotic liver disease, viral hepatitis, autoimmune hepatitis, cholestatic liver disease and hemochromatosis

Exclusion Criteria:

  • <18y
  • Acute hepatitis
  • Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDTA tube
Other: Blood draw for biomarkers
EDTA tube Blood draw for biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of biomarkers in blood and fibrosis stage of liver
Time Frame: Day 1 of the study
correlation of biomarkers in blood and fibrosis stage of the liver (comparison with: transient elastography, fib4, APRI and liver biopsy if possible)
Day 1 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoMis Fib

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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