Identification of Liver Fibrosis Biomarkers

Sponsor
Roche Diagnostics GmbH
Study ID
NCT06819917
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Identification of liver fibrosis biomarkers — OTHER
    Patients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made (routine biopsy). This decision can be based on standard liver function tests AST, ALT, FIB-4 (performed up to 8 months before biopsy), fibroscan (performed up to 6 months before biopsy) or other factors. In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan.

Study Details

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.

Key Dates

First listed
Feb 11, 2025
Start date
Feb 1, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
575 participants (estimated)

Primary Outcome Measure

Identification of Significant Fibrosis (≥F2) [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

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