We are establishing a Good Clinical Laboratory Practice (GCLP) facility in Leeds building on our GCLP experience in the ECMC-supported Clinical Trials Pharmacokinetic Laboratory in Bradford. This has been overseen by a newly appointed GCLP Q.A. manager working between Leeds and Bradford.

We are in the process of opening 8 early clinical trials including the Phase I study of GSK1070916A for which we the lead centre (Professor Chris Twelves; with London Barts ECMC). This is first compound to enter the clinic through the Clinical Development Partnerships programme as a collaboration between Cancer Research UK and GlaxoSmithKline. Patients will be managed in Leeds through the OCRF; we are currently installing and commissioning a designated research PET-CT scanner in Leeds that will be used for functional imaging studies (Dr A Scarsbrook). We will carry out pharmacokinetic assays in the ECMC-supported GCLP Clinical Trials Pharmacology Laboratory at the Institute of Cancer Therapeutics, University of Bradford (Dr P Loadman); the assay has been validated and an audit carried out by Cancer Research UK.

We have an extensive programme of tissue collection and banking for:

• Proteomic biomarkers (Professors R Banks and P Selby) include frozen or FFPE tissues, and clinical fluid samples, from patients with renal cancer collected prospectively for diagnostic, prognostic and predictive purposes; paralleling this, fluids are also being banked from healthy controls and patients with benign renal and urological conditions. We are establishing a GCLP sample processing facility.
• Molecular pathology (Professors P Quirke and M Seymour) have established extensive tissue banks, many linked to large Phase III clinical trials. We also established GIFT, the Leeds Tissue Bank of cadaveric tissue (Professor P Quirke), providing metastatic tumour tissue for researchers and establishing in Leeds the Breast Cancer Campaign Tissue Bank (Dr V Spiers and Professor A Hanby).
• In biotherapies we collect a range of tissue and blood samples from patients receiving novel therapies for immunological and other assays (Professor A Melcher); adolescent and childhood cancers samples are also banked (Professor S Burchill).
  

In Hull (Professor L Turnbull) we have completed the NHS R&D HTA funded COMICE trial examining the cost-effectiveness of MRI in staging women scheduled for wide local excision for treatment of primary breast cancer. Recruitment has also commenced for Cancer Research UK funded study evaluating the efficacy of advanced semi-automated functional MR Imaging in the early prediction of response of locally advanced breast cancer to neo-adjuvant chemotherapy

We have an extensive programme of early clinical trials of cell-based (with the local NHS Blood and Transplant service), vaccine, cytokine and virus (as single agents and in combinations with chemo- or radiotherapy) biological therapies (Professor A Melcher). Patients are treated in our OCRF isolation in-patient beds and studies incorporate laboratory and imaging translational studies.

We have particular strength in proteomics and biomarker studies in renal cancer. We (Professors R Banks and P Selby, Dr P Harnden) are participating in the CAGEKID programme to genetically map kidney tumours. We (Professors R Banks and P Selby) have also published one of the largest and most comprehensive and stringent studies characterising the genetic and epigenetic involvement of the VHL tumour suppressor gene in the development of sporadic conventional RCC and its significance relative to clinic-pathological characteristics and outcome.