Blood biomarker signatures to detect liver fibrosis in chronic liver disease
Assessing Signatures for Fibrosis Detection in Chronic Liver Disease: A Step Beyond Conventional Biomarkers.
We will test whether a set of blood biomarkers can show how much liver fibrosis an adult with chronic liver disease has.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07359742 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study will collect blood samples and perform transient elastography (FibroScan®) in adults with chronic liver disease from any cause to measure biomarker signatures and correlate them with fibrosis stage. The rationale is that hepatic stellate cell (HSC) activation precedes and drives fibrosis, so markers of HSC activity may be more sensitive than conventional fibrosis measures. Participants will undergo blood draws for biomarker assays and noninvasive liver stiffness measurement, and results will be analyzed across a larger, multi-etiology cohort. Patients with acute hepatitis or contraindications to FibroScan (for example ascites or overt heart failure) are excluded.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic liver disease of any etiology (alcohol, metabolic dysfunction-associated steatotic liver disease, viral hepatitis, autoimmune hepatitis, cholestatic liver disease, or hemochromatosis) who can undergo transient elastography are ideal candidates.
Not a fit: Patients under 18, those with acute hepatitis, or those with contraindications to transient elastography such as ascites or overt heart failure are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could enable earlier and more sensitive detection of liver injury using a simple blood test and reduce reliance on invasive biopsies.
How similar studies have performed: Previous biomarker panels and some HSC-activation markers (for example PRO-C3 and other fibrosis panels) have shown promise in smaller or etiology-specific studies, but broad validation across all causes of chronic liver disease is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brussels
- UZ Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Silke François
- Email: silke.francois@uzbrussel.be
- Phone: +32 2 477 60 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.