Assessing Signatures for Fibrosis Detection in Chronic Liver Disease: A Step Beyond Conventional Biomarkers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18y
Chronic liver disease: alcohol, metabolic dysfunction associated steatotic liver disease, viral hepatitis, autoimmune hepatitis, cholestatic liver disease and hemochromatosis
Disqualifiers
<18y
Acute hepatitis
Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.
Trial design
Design model
Single group
Treatments tested in this trial
Blood draw for biomarkers
Other interventionEDTA tube Blood draw for biomarkers
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: EDTA tubeExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Day 1 of the studySponsors and contacts
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Source ClinicalTrials.gov