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Identification of Liver Fibrosis Biomarkers

Recruitingn/aAges 18 Years - 75 YearsAllRoche Diagnostics GmbH
NCT06819917 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL/NASH) or patients with MASLD or MASH * Any FIB-4 value available * Any Fibroscan value available * Written and signed informed consent present * Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw * Body Mass Index (BMI) ≤ 45 kg/m² Exclusion Criteria: * Vulnerable person: person deprived of liberty by a judicial or administrative decision and/or person under psychiatric care * Self-reported pregnancy or lactating females * Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency * Any type of carcinoma, unless it is at least 5 years in remission * Prior liver transplant * Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed * Self-reported alcohol consumption greater 30 g/day (males) 20 g/day (females) * Recent myocardial infarction (within last 6 months) * Inability to have a liver biopsy, or provide blood sample in a fasted status * F0-F2 recalled patients with +/- 5% change in weight between the biopsy and study inclusion
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What it tests

  • Identification of liver fibrosis biomarkers
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Where

2 sites
Hvidovre Hospital
Copenhagen, Denmark
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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