The role of the Clinical Trials Core is to provide expertise in the development, implementation and coordination of all translational clinical trials resultant from the other SPORE projects that will ultimately lead to a better understanding of the biology of lung cancer. This improved understanding will ultimately lead to improvements in the treatment of lung cancer. To achieve this goal, the major responsibilities of the Clinical Trials Core will be 1) Provide expertise in the development and implementation of translational clinical trials related to the other SPORE projects 2) Accrual of patients to participate in SPORE initiated trials, 3) Timely and accurate collection of data, and 4) Accessibility of data for analysis by the various SPORE researchers at Vanderbilt university as well as researchers at other Lung SPORE sites. During the first year there will be at least seven translational trials open for accrual. These trials will serve to further the scientific knowledge regarding the role of 1) molecular fingerprinting and outcome analysis in resectable patients with lung cancer and 2) angiogenesis in lung cancer. More specifically, the impact of matrix metalloproteinases and their inhibition; the role of VEGF and its inhibition; the role of COX-2 and its inhibition on the outcomes of patients with lung cancer treated with either surgery, radiation, chemotherapy and/or their combination in patients with lung cancer. Over the five year course of the SPORE grant, trials will open and close. One of the goals of this SPORE is that the successful completion of these early pilot trials will ultimately lead on to larger scale, multi-institution trials for confirmation of our results. A second goal is that additional translational clinical trials will be designed based upon the results of the early pilot trials as well as the ongoing research of the participating SPORE investigators. The current pilot trials will thus serve as the template for further translational research in lung cancer.
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