Leeds NIHR Biomarker Research Tissue Bank

• Research type

  Research Tissue Bank

• IRAS ID

  171649

• Research summary

  Leeds NIHR Biomarker Research Tissue Bank

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  15/YH/0099

• Date of REC Opinion

  9 Apr 2015

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Blood and urine samples are processed promptly at each centre by either the research nurse or staff of the Clinical Chemistry labs in accordance with SOPs and frozen in multiple aliquots at -80°C until shipped. Tissue samples (formalin fixed paraffin embedded (FFPE) blocks (all centres, including LTHT) and frozen tissue (LTHT only)) are processed at each centre by dedicated research technicians in the Pathology department as part of the routine tissue processing procedures, with specific blocks being prepared for this RTB. All samples (tissue and biological fluids) are shipped by courier and stored at an HTA licensed establishment (University of Leeds/Leeds Teaching Hospitals NHS Trust – license number 12352) in compliance with the Human Tissue Act (2004). Each set of fluid samples are mirror banked between two secure -80°C freezers monitored for temperature fluctuations by a central alarm system, with the freezers being located in secure rooms. FFPE tissue blocks will be stored in a secure filing system within the banking facility. In all cases, samples are pseudonymised and assigned unique storage numbers. Their locations are recorded on Medical Achiever. Sample locations are also recorded on the group’s SENTRY LIMS system.

• Research programme

  The Leeds NIHR Biomarker research tissue bank (RTB) has been established through a National Institute for Health Research (NIHR) programme grant, which aims to rapidly identify and develop protein biomarker assays with appropriate characteristics to justify evaluation in the NHS. The principal focus is on renal (kidney) cancer and kidney transplantation. Liver disease is also covered under a separate ethical approval involving a clinical trial of new biomarkers. In all these diseases there are clear identified and unmet needs for better biomarkers. These may enable earlier diagnosis, provide prognostic information, allow monitoring for relapse or provide information to enable better selection and monitoring of therapies depending on the clinical context. The bank is established primarily to provide samples for use within the remit of the NIHR programme. However, the bank also provides samples for other appropriate research projects carried out by other research groups locally or elsewhere to maximise its use. Access to the bank is open to any ethically-sound parties with high quality "Biomarker" research proposals of genuine value to the public, scientific community or health service. Priority is given to collaborative applications and groups. Applications from commercial companies will only be considered if they are collaborative.

• Storage license

  12352

• RTBTitle

  Leeds NIHR Biomarker Research Tissue Bank

• Establishment organisation

  Leeds Teaching Hospitals NHS Trust

• Establishment organisation address

  St James's University Hospital

  Beckett Street

  Leeds

  LS9 7TF