New cancer centre biobank adopts LIMS to aid the management of its sample process
The newly established Clatterbridge Cancer Centre Biobank is just one part of a multi-million pound project to transform cancer care in Merseyside and Cheshire, UK. The biobank will act as a major resource for academic oncologists and help further build links between the Clatterbridge Cancer Centre, Liverpool University and key research partners. Matrix Gemini has a proven track record with other biobanks in the city and with the Liverpool GCLP facility that collects, stores and analyses samples from clinical trials.
BACKGROUND
The Clatterbridge Cancer Centre (CCC) is one of the largest networked cancer centres in the UK, serving 2.3 million people and treating over 27,000 patients a year over 10 operating sites across Merseyside and Cheshire. In a major new expansion of cancer services for the region, a new CCC is being built in the heart of Liverpool, alongside Royal Liverpool University Hospital, the University of Liverpool and Cancer Research UK’s Liverpool Cancer Trials Unit. The new hospital will provide patient-centred care, to meet the increasing demand for specialist cancer care as the population ages, and diagnosis and treatments improve. Patients will also be able to access a much broader range of clinical trials. In addition, cancer experts from the different hospitals, the university and key research partners will be working closely together, offering new scope for research. The CCC Biobank has been established to provide biological samples linked to patient outcome data to facilitate good quality research into the molecular mechanisms of cancer. The samples will be supplied by CCC patients diagnosed with cancer (following full informed consent) as well as by ‘healthy volunteers’ who have not been diagnosed with cancer in order to provide age-matched controls.
CHALLENGES
Blood (processed to plasma and serum, cellular material and buffy coat), urine, ascites fluid, saliva and sputum are to be collected from CCC cancer patients, while blood (processed to plasma, serum, cellular material and buffy coat) is to be collected from healthy volunteers. The CCC Biobank will support basic research in translational and novel biomarker studies. Blood serum and plasma are one the largest source of biomarkers. The samples will be used for cancer research procedures including discovery and validation of:
• Diagnostic biomarkers
• Prognostic biomarkers
• Predictive biomarkers
• Biomarkers for emerging drug resistance
• Biomarkers of toxicity
• Research into the molecular mechanisms of cancer
• Detection techniques
The biobank samples need to be tracked at all times and it is essential to be able to record the complete genealogy for all samples and track aliquots, pooled samples and derivatives of each sample, right the way through each use for research to complete sample consumption or final disposal.
Key requirements for the system include:
• Full compliance with all regulatory guidelines such as HTA,
GCLP, MHRA, FDA 21 CFR Part 11
• Full management of sample collection and registration, sample shipments, storage, sample picking/shipping and disposal
• Full sample tracking including parent/child samples, aliquots, derivatives etc.
• Complete location recording e.g. freezer, shelf, container and container position
• Storage location auditing and reconciliation with chain-of-custody reporting
• Audit trail of all changes
Although sample collection and storage will initially take place at a single location, there should be provision to allow collection at more than one centre at a later date, if required, meaning that the system should be capable of accommodating any future changes that may be needed.
SOLUTION
CCC investigated LIMS from different suppliers before choosing Matrix Gemini from Autoscribe Informatics. Matrix was already successfully in use in a biobank application at the Roy Castle Lung Cancer Foundation and at the Liverpool Good Clinical Laboratory Practice facility, which collects, stores and analyses samples from clinical trials. Its role-based security was another factor in its adoption; only people with the appropriate level of authority have access to different parts of the system. It also offered the comprehensive audit trail capabilities that CCC required.
In configuring the system for the CCC Biobank, Autoscribe worked closely with CCC on the user requirements, attended meetings related to the project and made many useful suggestions as the project evolved. As a result, the implementation of the system was carried out easily and efficiently, issues such as the NHS firewall were accommodated straightforwardly and project deadlines were met.
BENEFITS
The system went live in September 2015. In addition to fulfilling the needs for sample tracking in the biobank, there are some additional key benefits. The entire project was accomplished within the NHS Trust budget allocation. The Matrix Configuration Tools provide the flexibility to allow the system to be readily modified to accommodate future requirements (such as sample collections from multiple sites). The Matrix Configuration Tools are also designed for use by end users, so CCC could choose to make their own changes after suitable training.
