Identification of Liver Fibrosis Biomarkers

May 22, 2026 updated by: Roche Diagnostics GmbH

Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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. This decision can be based on standard liver function tests AST, ALT, FIB-4 , fibroscan 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 (if patients consent for further use, to be performed latest 6 months after biopsy).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Significant Fibrosis (≥F2)
Time Frame: Through study completion, an average of 1 year.
The study aims to identify significant liver fibrosis (stage F2 or higher) through various biomarkers. This involves the comparison of biomarkers to biopsy results to determine their predictive value .
Through study completion, an average of 1 year.
Identification of Advanced Fibrosis (≥F3)
Time Frame: Through study completion, an average of 1 year.
he study aims to identify advanced liver fibrosis (stage F3 or higher) through various biomarkers. The assessment will determine the predictive value of these biomarkers for advanced stages of fibrosis (F3-F4)
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of Biomarkers in Clinically Relevant Subpopulations
Time Frame: Through study completion, an average of 1 year.
Exploratory analysis to evaluate the performance of identified biomarkers within specific patient sub-groups. This aims to understand the variability and reliability of biomarkers across different demographics and clinical characteristics.
Through study completion, an average of 1 year.
Evaluation of Biomarker Panels
Time Frame: Through study completion, an average of 1 year.
This measure involves evaluating individual or combined biomarkers identified through literature review, pathway analysis, and experimental programs using a panel of well-characterized blood specimens (serum, plasma, whole blood, and buffy coat).
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roche Diagnostics GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD006521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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