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| Biological Studies
UKCCSG Biological Studies Newsletter - June 2005 Issue: 13 Welcome to Issue 13 of the Biological Studies Newsletter. Meetings/ConferencesThe NCRI Cancer Conferenceis to take place 2-5th October at the International Convention Centre in Birmingham - www.ncri.org.uk/ncriconference There will be a paediatric day as part of the symposium and this will include a plenary session, selected oral presentations and poster display. Biological Studies ApplicationsThe first application submission deadline under the new process was 15th May. Three applications were received and these are now being processed. The three applications are:-Dr Michael Sullivan – The pathogenesis and prognostic stratification of hepatoblastoma (and hepatocellular carcinoma) by microarray gene expression analysis. Dr Denise Sheer – Molecular genetic characterisation of low-grade paediatric astrocytic glioma. Dr C Zwaan – Genomic and protemic profiling in correlation with MRD, drug resistance and angiogenesis in paediatric AML. The next submission date is 15th August. Tissue Registration UpdateThere are currently 2602 specimens within the tissue bank. Registrations for 2005 are –
Tumour Bank MREC UpdateNational ethical approval for the Tumour Bank was originally obtained 1998. So much has happened since then. Importantly, leukaemia samples are now incorporated and henceforth the bank will be known as the UK Childhood Tumour and Leukaemia Bank. This allows for the use of one consent form and information sheet for all cancer samples. We have managed to retain the important principle that consent is generic (non-restrictive) and covering current and future research. Clearly ethical approval for any particular research study still has to be obtained through Trent MREC. The consent process also covers use of samples stored in local centres for research in that centre, again with the proviso that local ethical research approval is obtained. Patient Information Sheets have been amended to shorter bullet point versions, and to include the newly advised age range PIS. There is no assent form; young patients can sign the Consent Form. The consent form has 2 individual boxes to cover nationally approved and local research. Previously we have relied on centres sending in the consent form to UKCCSG Data Centre. However, this was an anomaly in that a similar requirement did not exist for clinical trials. We have therefore devolved the responsibility to centres asking them to ensure that material only goes into the UKCCSG tumour bank when consent has been obtained. There are three registration forms – LRF, Tumour Bank and Constitutional DNA. We ask that a designated person, research nurse or medical staff, prints name and signs to confirm that consent has been obtained. The Leukaemia Cell Bank covers samples for leukaemia trials only, and currently this only involves ALL2003. Storage of leukaemia samples locally or for other national research is covered by generic consent. Where pathology blocks are requested as well as a set of slides, this tumour will be registered using the form 1A and the samples retained at the central pathology review lab. We have recently revised our application procedure for solid tumours as detailed in previous newsletters. For leukaemia studies the initial concept should be submitted to relevant leukaemia task force and a full app made to the Biological Studies Division. Most biological studies fall into the no-local investigator category and so, once MREC approval obtained, this covers all UKCCSG centres without the need for each centre to put the biological study through their local ethics and R&D procedures. This is an important step forward as it reduces the bureaucracy that was holding up several research studies. Regarding release of archival tissue for which no consent in Tumour Bank, clarification has been obtained that all samples obtained prior to date of original LREC approval for Tumour Bank can be released, as long as they are registered in Tumour Bank. Samples not currently registered but needed for specific projects can be released if registered subsequently. As always, there are areas for improvement. One of the major frustrations for researchers is the timely release of samples. Presently this is too slow reflecting the devolved nature of the tumour bank, with 15 centres storing material; the problems linking clinical trials and tumour bank databases; complexity of project approval process; new MREC procedures. We are working on all of these aspects including a new biological studies IT database and the possibility of centralisation of tumour banking. Kathy is now handing over role of CI for Tumour Bank to Dr Isabella Moore, Pathologist. CR UK looking at centralized tissue bank. We are pleased to announce that we received a supplementary grant from CR UK to help with aspects of the TB including additional research nurse time, and also production of Parent/Patient Information Sheets and other promotional and educational material. We are still unsure about the implications of the HTA, which will become law in April 2006, and we will keep you updated as this unfolds. The BMJ will shortly be publishing an analysis of media reporting of children’s tissue storage for research in relation to registrations in the tumour bank. Tumour Bank AuditIt has now been almost a year since we changed the method of funding to centres for the storage and banking of tumour samples for research. Having changed the method of payment it is important to ensure that we can demonstrate an improvement in tumour banking and that centres are striving to achieve the targets that were set. We will therefore be conducting a centre by centre audit in August to check on progress. Your assistance with this will be most appreciated. Diary Dates 200516th August – Biological Studies Committee conference call – details to be confirmed 8th November – Biological Studies Committee followed by Division of Therapeutics, 44 Lincoln’s Inn Fields 14th December – Biological Studies Committee conference call – details to be confirmed Newsletter distributionThis newsletter is distributed to all members of the Division of Biological Studies, UKCCSG Centre coordinators, UKCCSG Centre Data Managers, Research Nurses, Pathologists and Pathology personnel in Centres, and to all those on our database of scientists. It is also available under the Biological Studies icon on the UKCCSG website – www.ukccsg.org. If you know of any other colleagues who may wish to receive a copy, please forward contact details to Sue Thornton, st22@le.ac.uk.
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