Actively Recruiting
Prospective Sample Collection for Discovery and Evaluation of Blood-Based Biomarkers to Assess Hepatic Fibrosis
Led by Roche Diagnostics GmbH · Updated on 2026-05-27
575
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating novel blood-based biomarkers to help diagnose and assess the stage of liver fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). These conditions can lead to serious liver problems including cirrhosis, liver failure, and liver cancer. The study also explores quantitative ultrasound combined with artificial intelligence to improve fibrosis assessment, aiming to find less invasive and more accurate diagnostic methods than liver biopsy. Participants will be recruited either when they are scheduled for a routine liver biopsy or recalled if they had a biopsy within the last 6 months and meet specific criteria. Blood samples and ultrasound scans will be collected to analyze potential biomarkers. The study is observational and involves no investigational drugs or treatments but focuses on gathering and evaluating clinical data and specimens. During the study, participants will provide blood samples and undergo ultrasound scans to assess liver fibrosis. Researchers will monitor the identification of significant and advanced fibrosis over about one year. Various biomarker panels will be evaluated for their performance in different patient groups. Participants' body mass index and other health factors will be recorded to support the research, with ongoing safety and data monitoring throughout the study period.
CONDITIONS
Brief Title
Identification of Liver Fibrosis Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for liver biopsy or with fibrosis stage F0-F2 who had a biopsy within the last 6 months but at least 1 month ago
- Suspected hepatic fibrosis due to NAFLD (NAFL/NASH), MASLD, or MASH
- Any available FIB-4 value
- Any available Fibroscan value
- Written and signed informed consent
- Age between 18 and 75 years at blood draw
- Body Mass Index (BMI) of 45 kg/m² or less
You will not qualify if you...
- Vulnerable persons under judicial or psychiatric care
- Pregnant or lactating females
- Liver disease from other causes including alcoholic liver disease, MetALD, specific etiology SLD, viral hepatitis, autoimmune liver diseases, HIV, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency
- Any carcinoma unless in remission for at least 5 years
- Prior liver transplant
- Unstable or untreated serious immunological, neoplastic, endocrine, hematological, gastrointestinal, neurological, or psychiatric disorders (medically controlled comorbidities allowed)
- Alcohol consumption over 30 g/day for males or 20 g/day for females
- Recent myocardial infarction within the last 6 months
- Inability to undergo liver biopsy or provide fasted blood sample
- For recalled F0-F2 patients, weight change of more than 5% between biopsy and study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo blood draws and ultrasound scans to collect samples and assess liver fibrosis biomarkers.
1 to 2 visits depending on biopsy timing
Duration - Approximately 1 year
Participants are observed for up to one year to evaluate the performance of liver fibrosis biomarkers.
Visits as needed for follow-up assessments
Trial Site Locations
Total: 2 locations
1
Hvidovre Hospital
Copenhagen, Denmark
Actively Recruiting
2
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Actively Recruiting
Research Team
Y
Yara Pujol Lopez, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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