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Tissue Collection Tissue collectionAll patients who are approached by their treating urologist and agree to donate specimens are asked to give written informed consent for the tissue banking protocol. A comprehensive patient information sheet covers all aspects relevant to the study, ie purpose of collection, how the tissues and data are collected, risks involved, confidentiality, patient rights, use of the tissue, and contact persons. The consent form gives permission for collection of blood and prostate tissue, and gathering of patient demographics, collection of clinically relevant information, and tracking of patient progression after treatment, for inclusion in the BioResource database. Consent is also obtained where appropriate for application of patient questionnaires. A blood sample is usually collected on the day of consenting, or immediately before surgery. Following radical surgery, prostate tissue is sampled according to the procedure developed by the participating site in consultation with the urologists and pathologists concerned. This method provides the highest quality of surgical pathology for the patient, while allowing sufficient cancer and non malignant tissue to be banked for future research. Only after all diagnostic pathology requirements are met will the tissue be released for research purposes. Tissue samples are collected prior to tissue fixation of the prostate. Usually between two to six 5mm or two 8mm punch biopsy cores, or two scalpel-removed samples are taken depending on the pathology service and the size of the prostate. Tissue bank personnel ensure that the donated specimens are frozen in the shortest possible time after removal of the prostate from the patient, and this time (preferably within 30 minutes) is recorded for tissue bank quality control purposes. Long delays in sampling permit degradation of RNA and cellular membrane proteins due to the high level of enzyme activity within the prostate. During 2005/2006, da Vinci robot-assisted radical prostatectomy was introduced into several centres in Australia, and the proportion of radical surgery procedures utilizing this advanced technology is expected to progressively increase over the next 5-10 years. Although robotic surgery is of benefit to the patient in terms of reduced blood loss and shorter stay in hospital, the procedure results in an increased delay between the severing of the prostate blood supply and removal of the organ from the patient. This period of warm ischaemia (lack of oxygen) at body temperature can lead to changes in cell morphology visible under the microscope, but there is apparently little adverse effect on mRNA quality at the molecular level. A study to compare the immunostaining profile of tumour biomarkers between prostate tissues derived from conventional and robot-assisted radical prostatectomy is being conducted by the BioResource. The tissue collection being progressively acquired by the BioResource nodes comprises prospectively collected fresh frozen prostate tissue, blood plasma and serum, and white blood (buffy coat) cells. Samples of ejaculate and post ejaculatory urines for biomarker studies and isolation of metastatic cells are being collected by researchers in Brisbane and would be available on a collaborative research basis, to be arranged via the Project Manager. Tissue Micro-Arrays are being progressively constructed from paraffin-embedded prostate cancer blocks extracted from existing pathology archives, where the tissue blocks may be associated with up to 5-7 year data on clinical follow up of patient disease outcome. Phase I Resources AvailableEach node has a collection of frozen and paraffin-blocked tissues that predates the formation of the BioResource. These collections have Institutional ethics approval for use in collaborative research with the team of investigators at the node concerned. Researchers may contact the National Project Manager with an outline of an ethically approved project and their tissue requirements. The Project Manager will then attempt to facilitate collaboration by contacting each node to determine whether they have the necessary tissue and data resources available. Phase II Resources - Tissue Micro-Array AvailabilityAs indicated in the outline of phase II operations of the BioResource (see About Us section), some TMA sets have been released. TMA sets currently available are:
All TMAs produced by the BioResource use 1mm tissue cores, usually in triplicate, with cancer and control non-malignant tissues from approximately 25-30 patients per block. Access to these resources is granted under the conditions outlined in the Tissue Access Policy document (see below). Partial cost recovery fees are applicable (see below). Phase III Resources – Frozen Tissue AvailabilityAs indicated in the outline of phase III operations of the BioResource provided in the About Us section, the prospective collection of tissues was initiated at all four nodes between October-November 2005. Also as indicated in the About Us section, release of the stored tissues from any single patient will be staged, with half being released immediately, and half after accumulation of 5 year clinical follow up data. No prostate tissue samples are released to researchers without a comprehensive pathological review to confirm either non-malignant or malignant status, and if the latter the proportional volume of cancer. The BioResource strives for a quality product. The average RNA Integrity Number (RIN, Agilent Technologies) for 80 individual prostate tissue samples tested is 9.2. A Priority Access Policy for a reserve collection is in place for tissue contributory groups and other members assisting BioResource operations, for information please consult the Project Manager. At the end of December 2009 (49 month accrual point), the BioResource prospective collection contained the following for early stage prostate cancer treated by radical surgery: Cost Recovery and Priority Access Policy A partial cost recovery programme is in place. Fees will be reviewed annually and details can be obtained from the Project Manager. The full fee structure is payable by researchers not associated with the BioResource tissue collection or management for both frozen prospectively-collected tissues and for paraffin-embedded micro-arrayed tissues, but a discount applies for members of the BioResource. For further information please contact the Project Manager. In order to conserve the tissue resource, frozen prostate tissue and blood products will be released only to highly rated projects of Australian researchers. Access for commercial / Pharmaceutical / Biotechnology companies, and for overseas researchers will require an Australian collaborator. Please contact the Project Manager for further information. Current fees until December 2010 are: Prospectively collected tissues: Tissue microarrays: Mouse (TRAMP) pilot and test arrays, to be determined, please consult the Project Manager. Freight for frozen tissues (on dry ice) and microarrays (on wet ice) will be at the current commercial rate from the Institute holding the materials. There may be several freight bills for frozen tissues depending on the institutes from which they are derived. Ethics ProformaThe Ethics Sub-Committee of the BioResource has reviewed a number of patient information sheets and consent forms approved by local Institutional Ethics Committees (IEC) and in use by the contributing nodes. A proforma for both patient information sheet and consent form can be provided by the Project Manager as a guide for investigators wishing to access materials, and who may need to demonstrate to their IEC the consent under which research tissues have been procured by the BioResource. Researchers can access the following document either via the link provided below, or by email from the Project Manager Proforma, participant information sheet Recommended Standardised Guidelines for Collection & Storage Procedures - For Prospective CollectionsThese guidelines are available from the Project Manager Tissue Access PolicyThe BioResource has developed a tissue access policy using the guidelines provided by the NMHRC for tissue banks funded via the Enabling Grant initiative. Researchers can access copies of the following documents either via the link provided below, or by email from the Project Manager Letters of Intent: |
