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

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Chronic Liver Disease (CLD); Fibrosis of Liver

Treatments: Other: Blood draw for biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT07359742

CoMis Fib

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

EDTA tube

Experimental group

Treatment:

Other: Blood draw for biomarkers