The Translational Research Core (TRC) enables clinical research at Case Comprehensive Cancer Center (Case CCC) by providing services that are critical for the generation of correlative data associated with clinical trials. Services include (1) consultation or full service writing of methods sections and budgets for CTEP letters of intent (LOI), protocols, and grants;(2) acquisition, logging, processing, storing, and shipping of patient samples to assay laboratories as specified by each protocol;(3) endpoint assays such as Western blotting, enzyme (e.g., telomerase) and ELISA assays, and non-standard flow and laser-scanning cytometry or microscopic imaging;(4) data collection and entry into the central ONCORE database, data submission of administrative units, and completion and submission of reimbursement forms as per CTEP Translational Research Initiative (TRI) guidelines. The core is directed by John Pink with a staff of 6, occupies 650 sq. ft. of dedicated laboratory and office space in the Wolstein Research Building, and shares an additional 1025 sq. ft. of laboratory and office space in Rainbow Babies and Children's Hospital, and University Hospitals. The TRC was developed within the last funding cycle, and has become fully functional within the last year. Since inception in 2002, the core has participated in 158 clinical trials. In 2006-2007, this workload is expected to increase to -4500 samples. The current total operating budget is $257,000. The Cleveland Clinic has a Clinical Pharmacology Program (CPP) directed by Ram Ganapathi, PhD. This laboratory, with a staff of 5, performs a similar function for clinical trials open at the Taussig Cancer Center. Currently this facility supports -125 trials with -1750 samples/2005 (past 5 year average, 1200 samples/year). The majority (75%) of samples are associated with industry sponsored trials;the remainder primarily investigator-initiated, cooperative group trials. Taussig investigator-initiated trials are expected to increase during the next five years, and as the Case CCC integrates investigators from both the Ireland and Taussig Cancer Centers, investigator-initiated trials will be open at both institutions. Therefore, the TRC will take a lead role during this time, coordinating communication and function within both the present TRC and the CPP to accommodate a smooth and seamless rendering of TRC services to all eligible trials. The operating budget will increase in year 2007 to accommodate this integration.
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