ADVANCE

  • Research type

    Research Study

  • Full title

    Accelerating Discovery: Actionable NASH Cirrhosis Endpoints (ADVANCE)

  • IRAS ID

    319278

  • Contact name

    Quentin Anstee

  • Contact email

    quentin.anstee@newcastle.ac.uk

  • Sponsor organisation

    Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    3 years, 10 months, 31 days

  • Research summary

    ADVANCE is a longitudinal cohort study supporting scientific research by members of the 'NASH Disease Translational Accelerator' (NASH-DTA) Consortium.

    The overarching aim is to leverage a greater understanding of disease pathophysiology to develop robust methods for diagnosis, risk stratification and therapy for patients with Non-Alcoholic Fatty Liver Disease related advanced liver fibrosis/cirrhosis (“compensated advanced chronic liver disease, cACLD”).

    To achieve this we will assemble a longitudinal observational cohort of well-characterised patients with Non-Alcoholic Fatty Liver Disease (NAFLD) related advanced liver disease/cirrhosis and collect clinical information, clinical imaging data (Ultrasound, MRI) and biological samples (blood, liver tissue, etc) for use in detailed multi-omics laboratory research into pathophysiology.

    The ADVANCE study consists of a screening/baseline assessment period, and a longitudinal observation period of 24-months for qualifying participants. Subjects will return to the clinical site on Months 6, 12, 18 and 24 (end of study) for assessments. In addition, subjects will be contacted by telephone at months 3, 9, 15 and 21 for remote assessments. Thereafter, the analysis phase of the project will continue for up to an additional 120-months with significant event capture via electronic medical records.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    22/NE/0234

  • Date of REC Opinion

    19 Jan 2023

  • REC opinion

    Further Information Favourable Opinion