Clinical trial NCT06819917: Identification of Liver Fibrosis Biomarkers
Official title: Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-alcoholic Fatty Liver
Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Lead sponsor: Roche Diagnostics GmbH
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Identification of Significant Fibrosis (≥F2)
timeFrame: Through study completion, an average of 1 year.
measure: Identification of Advanced Fibrosis (≥F3)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Performance of Biomarkers in Clinically Relevant Subpopulations
timeFrame: Through study completion, an average of 1 year.
measure: Evaluation of Biomarker Panels
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
References: