Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.
Condition: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; Liver Fibroses; Liver Inflammation; Liver Steatoses
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Hepatitis; Fibrosis; Inflammation
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the clinical performance of LIVERFAStTM In
      Vitro Diagnostic (IVD) Tests (Fibrosis score, Activity score and Steatosis score) in NAFLD
      suspected patients for staging of fibrosis and for grading of inflammatory activity and
      steatosis, taking as reference the liver biopsy with histological classification of the
      elementary lesions determined according to SAF scores (Bedossa P., Hepatology 2012).

      The secondary objective is to assess the performance of LIVERFAStTM for the histological
      definition of NAFLD, including NAFL and NASH and severe NASH
    

Detailed description: 
      Chronic liver diseases (CLDs), such as chronic viral hepatitis, nonalcoholic fatty liver
      diseases (NAFLD) and nonalcoholic steatohepatitis (NASH), are a leading cause of morbidity
      and mortality globally and usually develops over many years. The prevalence of NAFLD has
      increased in recent years (15% in 2005 to 25% in 2010) mainly due to the increase prevalence
      of obesity and diabetes. As, approximately 20% of NAFLD cases develop NASH, the associated
      increase in NASH during the same period is to be expected (33% in 2005 to 59.1% in 2010).

      As a result, staging of liver fibrosis is essential in determining the prognosis and optimal
      treatment for patients with NASH. Furthermore, evaluation of fibrosis in NAFLD patients can
      help refine treatment options designed to prevent the progression to NASH.

      One recent study demonstrates significant sampling variability of routine liver biopsy in
      patients with NAFLD (Ratziu V. et al. Gastroenterology 2008). The diagnosis of NASH would
      have been missed in 35% and the discordance for steatosis grading was encountered in 22% of
      patients.

      Developing safe and easily accessible noninvasive modalities to accurately evaluate fibrosis
      stage of NAFLD and NASH is of utmost importance in clinical practice.

      Fibronostics breaks through the burden to serve patients. By empowering their providers with
      IVD clinical tools within the clinic, the ability to ensure screening and clinical adherence
      is assured, and the ease for early detection profoundly shifts the $2B economic burden.

      LIVERFASt is a non-invasive clinical and staging In-Vitro-Diagnostic (IVD) tool, which has
      been developed as an alternative to liver biopsy. LIVERFASt is a safe, and reproducible tool
      which provides surrogate grading and staging of the three elementary features of NASH:
      steatosis, inflammatory activity and fibrosis.

      LIVERFAStTM combines age, gender, weight and height with common liver function tests (ALT,
      AST, GGT, total bilirubin), lipid profile (total cholesterol, triglycerides), fasting glucose
      and three specific proteins of the liver with hepatoprotective functions and predictive value
      in NAFLD -alpha2-macroglobulin (A2M), haptoglobin (HAP) and apolipoprotein A1 (APOA1).

      The main aim of this study is to evaluate the clinical value of LIVERFAStTM as a non-invasive
      biopsy-proven surrogate assessment of non-alcoholic fatty liver disease.

      This is a cohort cross-sectional prospective, multi-centre study of an algorithm-based
      assessment of liver fibrosis, inflammatory activity (steatohepatitis) and steatosis compared
      to the histological assessment provided by liver biopsy performed in patients with suspected
      non-alcoholic steatohepatitis (NASH).
    

Intervention name(s): LIVERFASt
Intervention type(s): Diagnostic Test
Intervention description(s): blood draw
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: LIVERFASt; Liver biopsy; Liver Fibrosis; Liver Activity; Liver Steatosis; Non-invasive serum biomarker; Neural Network; Artificial Intelligence Machine Learning; Algorithm based test