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

NCT07359742 — Not applicable, Recruiting, 110 participants, Universitair Ziekenhuis Brussel

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

Registry	NCT07359742
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	110 (Estimated)
Sponsor	Universitair Ziekenhuis Brussel (Other)
Conditions	Chronic Liver Disease (CLD), Fibrosis of Liver
Interventions	Blood draw for biomarkers (Other)
Dates	start 2026-05-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-01-22, last updated 2026-05-06
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
EDTA tube	Experimental	Other: Blood draw for biomarkers

Blood draw for biomarkers (Other): EDTA tube Blood draw for biomarkers

+Outcome measures

Primary outcomes

correlation of biomarkers in blood and fibrosis stage of liver [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)

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
UZ Brussel	Brussels	Belgium	Recruiting