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

NCT07359742 | Recruiting

• 1 other identifier: CoMis Fib
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease (CLD); Fibrosis of Liver

Keywords

chronic liver disease; fibrosis

Outcome Measures

Primary Outcomes (1)

• correlation of biomarkers in blood and fibrosis stage of liver

  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

Study Arms (1)

EDTA tube

EXPERIMENTAL

Other: Blood draw for biomarkers

Interventions

Blood draw for biomarkers OTHER

EDTA tube Blood draw for biomarkers

EDTA tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Interventions

Blood Specimen Collection; Biomarkers

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Factors

Central Study Contacts

Silke François

CONTACT

+32 2 477 60 11; silke.francois@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)