Actively Recruiting
Identification of Liver Fibrosis Biomarkers
Led by Roche Diagnostics GmbH · Updated on 2026-02-24
575
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL/NASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.
CONDITIONS
Official Title
Identification of Liver Fibrosis Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for liver biopsy or with F0-F2 fibrosis biopsy within the last 6 months suspected of hepatic fibrosis due to NAFLD, NAFL, NASH, MASLD, or MASH
- Any FIB-4 value available
- Any Fibroscan value available
- Written and signed informed consent
- Patients aged 18 to 75 years at blood draw
- Body Mass Index (BMI) of 45 kg/m² or less
You will not qualify if you...
- Persons deprived of liberty or under psychiatric care
- Pregnant or lactating females
- Liver disease from other causes such as alcoholic liver disease, MetALD, specific etiology SLD, cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, HIV, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency
- Any type of carcinoma not in remission for at least 5 years
- Prior liver transplant
- Unstable or untreated significant immunological, neoplastic, endocrine, hematological, gastrointestinal, neurological, or psychiatric disorders (medically controlled comorbidities allowed)
- Alcohol consumption greater than 30 g/day (males) or 20 g/day (females)
- Recent myocardial infarction within last 6 months
- Inability to have liver biopsy or provide blood sample in fasted status
- F0-F2 recalled patients with more than 5% weight change between biopsy and study inclusion
AI-Screening
AI-Powered Screening
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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
I
Ioanna Rokai, MSc.
CONTACT
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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