FibroScan: a study to identify subjects with steatosis and fibrosis

  • Research type

    Research Study

  • Full title

    FibroScan: a study to identify subjects with steatosis and fibrosis

  • IRAS ID

    270210

  • Contact name

    Jim Bush

  • Contact email

    jim.bush@covance.com

  • Sponsor organisation

    Covance CRU

  • Duration of Study in the UK

    0 years, 4 months, 16 days

  • Research summary

    Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disease ranging from steatosis (fatty liver) to liver cirrhosis and hepatocellular carcinoma.

    NAFLD has a number of stages, the first recognisable stage being non-alcoholic fatty liver (NAFL) which is characterised by fatty infiltration of the liver. At this stage there is no evidence of liver injury such as elevated liver enzymes or fibrosis. The next stage of the disease is non-alcoholic steatohepatitis (NASH) in which there is fat accumulation, with liver inflammation and a risk of fibrosis and cirrhosis (liver scarring) which may lead to hepatocellular carcinoma.

    FibroScan is a device which enables non-invasive measurement of steatosis and fibrosis in the liver. Covance has now purchased Echosens FibroScan Compact 530 in conjunction with FibroView software with the aim of creating and maintaining a database of subjects with steatosis and fibrosis for recruitment to studies where such subjects are required.

    This protocol is a screening protocol designed to identify subjects with liver steatosis and/or fibrosis for inclusion in the Covance database.

  • REC name

    Yorkshire & The Humber - South Yorkshire Research Ethics Committee

  • REC reference

    19/YH/0296

  • Date of REC Opinion

    1 Oct 2019

  • REC opinion

    Further Information Favourable Opinion