Achievements
In Glasgow, ECMC funding has been used to support a number of infrastructure developments which have both short term and long term aims to improve the quality and output of translational science projects.
We have used ECMC funding to (1) establish an Analytical Services Unit; (2) provide research nurse support to our clinical investigators, both for early phase studies and for phase III clinical trials when these involve complex and intensive patient sampling schedules; and (3) contribute support for the collection of patient samples, including tumour tissues, for the Glasgow Bio-Repository.
Analytical Services Unit (ASU)
We have put in place GCLP standards in our ASU. This allows us to use results from assays done within trials to influence clinical decision-making in real time. This makes these specific clinical trials more efficient, more likely to be informative, and this information can then be used to influence and improve the design of future studies and drug development. These have included a number of translational studies focusing on the application of epigenetic biomarkers in patient samples, predominantly from patients with ovarian cancer, and performed in collaboration with investigators at Imperial College, London ECMC. Many of these are multi-centre studies, carried out under the auspices of the Scottish Gynaecological Cancer Group or the NCRN, and include studies of both epigenetic therapies and conventional cytotoxic chemotherapy agents.
The ASU has developed and validated a number of diagnostic, pharmacodynamic, or prognostic biomarkers for application within specific clinical trials, or to answer clinically-relevant questions in patients undergoing standard therapy regimens. These have been predominantly in patients with gastro-intestinal cancer (both Upper GI cancers and colo-rectal cancers), and include measurement of plasma caspase-cleaved and total cytokeratin as a biomarker of tumour response and clinical outcome in advanced disease. We are currently exploiting our expertise in the biology of telomerase and cellular senescence to develop and validate novel biomarkers for application in gastro-intestinal cancer. In addition a number of assays are being developed to support studies in CML, bladder cancer, Carcinoma of Unknown Primary origin, and glioblastoma. The SCOT study (adjuvant study in colorectal cancer; n = 9,500) is open for recruitment, and includes the prospective tissue collection for translational studies, and will be one of the largest tissue resources with matched clinical outcome information from patients with early colorectal cancer.
Early Phase Drug Development
Glasgow is a leading centre for early phase clinical trials of novel anti-cancer agents. ECMC resource supported 63 early phase trials (phase I / phase II / proof of mechanism / proof of concept) in 2009, in addition to 12 biomarker trials, 4 new technology trials, and 58 phase III trials (in 2009) in patients with solid tumours or haematological malignancies (especially CML). We have a long established track record of first-in-human and first-in-class studies of novel therapies, with compounds from Industry, Cancer Research UK Drug Development Office, academic collaborations, and we are also a member of the EORTC Network of Core Institutions. Increasingly, these studies are carried out with agents that are relevant to our basic science programmes at the Glasgow Centre for Cancer Research (GCCR).
The GCCR encompasses basic and translational cancer research, creating a world-class environment to foster interactions and synergy between laboratory cancer researchers and clinicians. The key components include the Beatson Institute for Cancer Research (BICR), the BICR drug discovery program (DDP), the University of Glasgow including the Paul O’Gorman Leukaemia Research Centre, and the Beatson West of Scotland Cancer Centre. The BICR is internationally renowned for its basic cancer research, identifying novel targets for therapeutic intervention with a focus on cancer cell migration and invasion, and cancer cell proliferation, death, and survival, with massive investment and world-leading expertise in preclinical modelling and imaging. ECMC funding will support us in effectively interfacing our laboratory and clinical research, thereby maximising the translational opportunities of our clinical trials and enhancing the final study design and outcomes.