HCV Research UK Tissue Biobank V2

• Research type

  Research Tissue Bank

• IRAS ID

  322519

• Research summary

  HCV Research UK Tissue Biobank V2

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  22/EM/0272

• Date of REC Opinion

  2 Dec 2022

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Blood and urine samples are collected from patients with HCV infection, sent to Glasgow using courier services and aliquoted before storage using standard SOPs. Birmingham, Oxford and Nottingham act as satellite sites. Recruitment centres use a
  common barcoding system, assigning a unique number to each sample. The unique number links the sample to the patient’s study number and their clinical details. It also identifies the date of sample acquisition and nature of sample. All aliquots of the original sample are assigned new unique barcodes. Samples are logged in the Tissue Bank database - a management system for recording storage, location and use of samples. Patients are enrolled with written informed consent and data on their disease history, treatment and disease outcomes is stored in a separate but linked clinical database.

  Patients are assigned a unique Study Number, and all data and samples are recorded against that number with no patient identifiable data being held within the Tissue Bank database. The patient identity for study numbers is held in each clinic to ensure that no-one is entered twice in the Tissue Bank and to update the patient’s clinical outcomes.

• Research programme

  The Tissue Bank is a key component of the collaborative project, HCV Research UK, which provides key reagents, infrastructure and material to resolve crucial questions relating to the natural history and management of chronic HCV infection in the UK. The project was initially funded by the Medical Research Foundation and links 58 clinical centres across the country. These centres recruit patients and collect clinical samples to be stored in the Tissue Bank. The infrastructure combines patient characteristics with clinical material, thus enabling unparalleled studies on HCV infection in a large cohort of UK patients. Clinical samples support research across a wide range of disciplines to address key research questions on HCV infection, such as: • Sophisticated genetic analyses to determine host and viral factors associated with different disease outcomes. • Analysis of pre-existing mutations in infected patients that may confer resistance to the new generation of anti-viral drugs launched in the UK. • Studies on the HCV variants that are circulating in the various population groups and geographical regions across the UK, which will aid healthcare provision and strategies for intervention. • Identification of biomarkers of fibrosis progression and carcinogenesis.

• RTBTitle

  HCV Research UK Tissue Biobank V2

• Establishment organisation

  MRC-University of Glasgow Centre for Virus Research

• Establishment organisation address

  Sir Michael Stoker Building, Garscube Campus

  464 Bearsden Road

  Glasgow

  G61 1QH