Aim and mission
The Clatterbridge Cancer Centre has a well-defined mission to ‘improve health and wellbeing through compassionate, safe and effective cancer care’. Research for patient benefit is a fundamental part of the organisation to conduct high quality research which translates into improved treatment and better prognosis for our patients.
The establishment of a CCC Biobank aims to provide high quality biological samples linked to patient outcome data to facilitate good quality research into the molecular mechanisms of cancer, biomarker discovery for early detection of cancer, patient stratification and into the reasons why some cohorts of patients fail to respond to therapeutic agents; all of which it is hoped will result in tangible patient benefit. The sample collection is entirely prospective following full informed consent from our patients. The biobank will also store samples donated from ‘healthy volunteers’ who have not been diagnosed with cancer in order to provide age matched controls.
The samples will be used for the following cancer research procedures including, discovery and validation of:
- Diagnostic biomarkers
- Prognostic biomarkers
- Predictive biomarkers
- Biomarkers for emerging drug resistance
- Biomarkers of toxicity
- Molecular mechanisms of cancer
We envisage analysis of:
- Nucleic acids: cellular and circulating free-; tumour and germline cells - circulating tumour cells; immune/inflammatory cells
Using techniques including, but not exclusively: genomics, proteomics, transcriptomics, metabolomics and correlating all of the above with patient information and outcomes.
Sample and data collection
The samples will be collected following full informed consent; the type of samples to be collected will be:
- Anticoagulated blood for the preparation andstorage ofplasma, buffy coat and cellular material
- Coagulated blood for the preparation and storage of serum
- Ascites fluid
All samples will be collected following full informed consent and processed and stored in line with Standard Operating Procedures (SOPs) and Policy. The Biobank facilities and equipment will all be assured as ‘fit for purpose’ in line with SOPs. The samples will be stored in the CCC Research Laboratory (in a designated -86°C freezer) will be monitored, with Business and Disaster contingency plans in place. All staff will be fully trained on SOPs and all aspects of Biobank SOPs and Policy and Health and Safety requirements.
The samples will be anonymised using numeric, barcoded labels. The samples would be available to researchers upon application and following review by the Sample Access Committee. A Laboratory Information Management System (LIMS) will be used to map a full audit trail for the samples. The LIMS will have restricted, password protected access and will log all procedures undertaken with respect to the samples. Only Biobank staff will have access to the LIMS according to role. The LIMS and processes and procedures with respect to samples and data will undergo audit and review to assure the integrity of the samples and maintenance of the systems.
Samples from the CCC Biobank will be made available to all legitimate researchers from either the UK or abroad. The samples must be used to support cancer research as described above and as described in the Participant Information Sheet, in line with Research Ethics Committee favourable opinion and conditions and in line with the Human Tissue Authority License. The samples will be awarded on the merit of the proposal which will be reviewed following application by the Sample Access Committee (terms of reference in appendix 1). Researchers wishing to apply for samples to the CCC Biobank include:
- Academic scientists from recognised institutes
- Industrial scientists
- NHS scientists
- Scientists funded by charities
If the samples are rare in nature or if there is duplication in research, then priority would be given to CCC Researchers. However, if competing applications are submitted, the researchers will be encouraged to collaborate if possible. Samples will be requested by the completion of an application form the applicants should describe:
- Title of the Project
- Type and amount of samples
- Data required to accompany the samples
- Research to be undertaken (description of the research including background information, expected outcome, scientific and patient benefit.This must be in ‘laymans terms’ so that the proposal may be understood by members of the public).
- Institution where the research will be undertaken
- Principal and Co-Investigator’s CV including publication record
- Two independent peer reviews
- Funding and infrastructure to support the research for which the samples will be required
- Evidence of previous successful application and use of samples (this could be from another Biobank).
The information will be circulated to the Sample Access Committee for review; all Committee members will be asked to return the results of the review in writing within a 2 week time frame. The results of each member’s review will be circulated to the Committee to reach a consensus decision.If a consensus decision cannot be met, a teleconference will be convened or if a scheduled meeting is near, the application will be discussed as an agenda item. The Committee may require the lead researcher to attend a meeting to discuss the proposed project further if there are complicated issues involved. Once the request for samples has been approved, the samples will be shipped to the researcher on the signing of a Material Transfer Agreement (MTA).It is recognised that research performed on the stored samples could generate results that provide prognostic information for individual patients or inform on the risk of cancer in family members. A policy of not transmitting results back to individual research participants has been adopted. Responsibility for reviewing how the results of research projects might impact on clinical management will reside with the Biobank Governance Committee. The CCC Biobank will not request the return of any unused/ partially used samples, these should be destroyed by the Researcher as agreed in the MTA. The Researcher will also agree not to share data with any other party and the data must only be used in line with the approved proposal.
Responsibility of researchers
Researchers will be requested to provide feedback to the CCC Biobank on the progress of the study, findings and publications as defined in the MTA. However, the CCC Biobank will not be held accountable or responsible for the integrity or accuracy of the research findings. This will be a condition of sample access, where the Researchers will be required to return results to the biobank for the enrichment of data associated with the samples. It is also a condition of sample access that the Researcher acknowledges the CCC Biobank as the source of samples in all publications. The CCC Biobank will agree for its part to hold the returned data in confidence for not longer than one year before making it available for future research. The CCC Biobank will acknowledge the researcher as the originators of any data that is returned to it and which is made available to other scientists. The scientists using the data should acknowledge the original Researcher. There is an appeal process where if samples are denied to a Researcher they may appeal to the Biobank Governance Committee.
For more information contact Vicky Chekoldina, Biobank Administrator