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Study identifier: NCT06819917 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Identification of Liver Fibrosis Biomarkers

Condition: Non-alcoholic Fatty Liver · Non-Alcoholic Fatty Liver Disease · Non-alcoholic Steatohepatitis  ·  Sponsor: Roche Diagnostics GmbH

PhaseN/A
Planned participants575
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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 expl…

This description comes directly from the study's public registry record.

Talk to the study team

Yara Pujol Lopez, Dr.  ·  +4915254994070  ·  yara.pujol_lopez@roche.com

Always discuss trial participation with your own doctor first.

Locations (2)

Hvidovre HospitalCopenhagen, DenmarkRecruiting
Universitätsmedizin der Johannes Gutenberg-Universität MainzMainz, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT06819917