The Clinical Investigations Core of the Colorado Lung Cancer SPORE Application will support all clinical studies conducted by SPORE members and collaborators. A major thrust of the Colorado application is to translate laboratory advances in genetics and biology into clinically useful strategies for early detection, prevention and therapy. The Clinical Investigations Core will be responsible for (1) protocol development and review; (2) conduct of the clinical trials with all data management; (3) quality assurance and audits; (4) providing information and access to the clinical trials to the health care [UCHSC, Regional, National (PDQ)] and the lay communities (Rocky Mountain Clinical News, PDQ, newspaper articles); (5) coordinating clinical studies of the SPORE center with those of the Cancer Center and other groups (e.g. SWOG, etc.) and (6) promoting interactions between the basic and clinical scientists. At the outset of the SPORE application, 8 clinical trials are anticipated and are included with this application. These clinical trials include studies of early detection, prevention and therapy. These trials are all pilot investigations of new strategies. For example, B8509-035, a calcium/calmodulin/protein kinase C antagonist was developed in our basic studies of lung cancer growth factors. The SPORE will conduct phase I and early phase II studies of this and other agents. If these provide encouraging results, national studies using other funding mechanisms will ensue.
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