The Prostate Cancer Research Consortium Bioresource (Ireland)

The Prostate Cancer Research Consortium (PCRC) is a co-ordinated group of researchers and clinicians from universities and hospitals in Ireland whose aim is to improve the diagnosis and treatment of prostate cancer by engaging in biomarker discovery and validation research. The PCRC has established a prostate cancer bioresource that collects biological samples and comprehensive clinical information collected at time of recruitment and subsequent follow from prostate cancer patients undergoing Transurethral resection of the prostate (benign disease) or radical prostatectomy (indolent, significant and aggressive, Gleason Score 4–10). This disease based bioresource with potential for reuse has recruited ~900 patients and collected >10000 tissue, serum, plasma, urine, DNA and RNA samples.

(1) Bioresource Overview One of the objectives of the PCRC was to establish a bioresource. The first samples to be incorporated into the bioresource were collected in 2002. The PCRC established collection and temporal storage sites at its hospitals, following ethical approval by each of the hospital's ethics committees. The PCRC uses an agreed collection model, with agreed standard operating procedures (informed consent, sample collection, processing and transportation) that are implemented across the different sites, ensuring uniformity of the bioresource. Samples are temporarily stored at the collection centres using monitored storage facilities and periodically collected and transferred to the PCRC bioresource. They are then processed for long term storage. There is a bioresource management system that facilitates effective storage, retrieval, tracking and dissemination of biological samples.
The bioresource has a Bioresource Information and Management System (BIMS) which is a central data repository for the sample, clinical and research data. The BIMS data originates from the hospital and research sites. Research nurses upload de-identified clinical, sample and pathology data and PCRC researchers upload research data from biological assessment. Uploading is done over a secure web browser to ensure confidentiality and security. BIMS allows researchers to identify what samples are available and where they are located and associated clinical and biological assessment data.

Species
Human.

Classification (2)
Biological samples and associated clinical data.

Description
Ireland. All counties of Southern Ireland.

Temporal coverage
Start date 2002 to present; with collection, processing and storage of samples indefinite.

N/A.
(2) Methods Steps 1. Patients deemed suitable for recruitment are identified by research nurses. 2. Potential patients are contacted and informed consent sought. 3. After obtaining informed consent, research nurses organise with the patient to collect blood and urine samples prior to surgery. Tissues are collected at time of TURPs or radical prostatectomy. 4. Blood and urine samples are processed by the research nurses and temporarily stored at hospital sites. The tissues as processed by pathology laboratory staff and stored. All samples are processed using the agreed SOPs. 5. Clinical, pathological and sample data are recorded electronically into BIMS by research nurses. 6. Serum, plasma, urine and fresh frozen tissue (clarified in next section -Stabilization/preservation) are periodically collected from collection sites and transferred to the combined bioresource. FFPE blocks are stored at the pathology laboratories until required for biological assessment.
Standard Operating Procedures used include consent, sample collection, storage, retrieval, tracking and data management.

Stabilization/preservation
Bloods: vacutainer, EDTA, heparin. Tissue: tissue container, 10% formalin; tissues for FFPE are kept in formalin until processing (processed within 2 hours of collection), fresh frozen tissues are transferred to freezing container and frozen in a −80 o C freezer.

Source of associated data
Health records and questionnaires.

Ethics Statement
Informed consent: The informed consent is structured along the following headings; 1. What is the purpose of this research study? 2. Why have I been chosen? 3. Who is organizing this study? 4. What will happen to me if I take part? 5. Are there any disadvantages in taking part in this study? 6. Are there any possible risks of taking part? 7. What are the possible benefits of taking part? 8. What happens after the study? 9. Confidentiality-who will know I am taking part in this study? 10. Hospital Research Ethics Committee Approval. 11. What will happen to the results of the study? 12. Voluntary participation. 13. Further Research. 14. Contact details.
Mater Misericordiae University Hospital, St James's Hospital, Beaumont Hospital and the Adelaide & Meath hospital ethics committees.
There are ethical/legal limitations for the collection. The sample release and distribution does not breach Irish data protection legislation. The distribution of associated clinical data falls under the remit of the National Cancer Registry of Ireland (NCR). The NCR collects and distributes data on cancer patients in Ireland and is permitted to do so by specific data protection legislation. PCRC has partnered with the NCR. This allows the PCRC to focus on the biobanking and release of samples, and the NCR to focus on the dissemination of coded (de-identified) patient data, which thereby protects the privacy of individuals.

Constraints
Loss of patients leading to lack of follow up information and samples. Lack of long-term funding.

Access criteria
Complete access policy is in development and will be available on the resource website. Provisionally, access can be done case by case by contacting +353 (01) 716 6733 or a written demand can be sent to this address School of Medicine, Conway Institute, Belfield Dublin 4 Ireland.
(4) Reuse potential Biological samples and associated clinical data from the PCRC Bioresource can be reused for biomarker discovery and validation research that would improve detection, prognosis and treatment of prostate cancer. This would include (i) using the samples and applying genomic, transcriptomic and proteomic technologies to identify novel biomarkers for early detection and improved prognosis of prostate cancer cases; (ii) using the samples to validate their biomarkers and correlate these molecular characteristics with disease progression phenotypes; and (iii) using the samples to evaluate their novel therapies in pre-clinical and potentially Phase I and Phase II studies.

Additional Files
The additional files for this article can be found as follows: • Additional File 1: Figure 1. A flow diagram showing the link between the biobanking processes and research quality. This diagram illustrates the link between the biobanking processes and research quality. http://dx.doi.org/10.5334/ojb.12.s1 • Additional File 2: Figure 2. Representation of the biobank system design. This diagram illustrates the representation of the design of the biobank system. http://dx.doi.org/10.5334/ojb.12.s2 • Additional File 3: