Blood markers to detect liver scarring in fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort will collect blood samples from adults with NAFLD/NASH (including MASLD/MASH) who are scheduled for liver biopsy or had a biopsy within the past six months and will compare biomarker results to biopsy fibrosis stage, Fib-4, and FibroScan readings. Eligible participants are aged 18–75 with BMI ≤45 and must not have other known liver disease etiologies or be pregnant or lactating. The goal is to identify blood biomarkers associated with fibrosis stage to support noninvasive diagnosis and risk stratification. The project is sponsored by Roche Diagnostics and is taking place at centers in Copenhagen and Mainz.

Why it matters

Who can join: the full rules

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

Where it's running

• Hvidovre Hospital
  Copenhagen, Denmark Recruiting
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  Mainz, Germany Recruiting

Study contacts

• Study coordinator: Yara Pujol Lopez, Dr.
• Email: yara.pujol_lopez@roche.com
• Phone: +4915254994070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.