Clinical Trials Core

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The goal of the Clinical Trials Core is to provide support for clinical trials designed and implemented by SPORE project investigators. The support includes assistance with trial preparation, regulatory issues, data safety and monitoring, auditing, conduct, and reporting. Our ever increasing understanding of the molecular basis of lung cancer has created a need to continue studies which involve the collection of both clinical data and specimens for molecular analyses. This translational approach has allowed us to investigate biological pathways of lung carcinogenesis in human tissue and has acted as a powerful tool in the evaluation of novel, biologicallyrationale strategies for the prevention, screening and early detection of lung cancer. The Clinical Trials Core was created to encourage interactions between basic and clinical researchers to generate pivotal translational research clinical trials and provide the necessary infrastructure to develop and conduct clinical investigations. We offer expertise in clinical trial methodology, protocol writing, regulatory documentation and quality assurance measures. A robust clinical database has been established through the collaborative efforts of the Clinical Trials, Tissue Bank and Biostatistics/lnformatics Cores, including the collection of common data elements (CDEs) that allows the pooling of data from trials conducted at other investigational sites. We provide clinical research associates to accrue subjects and collect data/tissue samples for all SPORE-initiated trials. All data is entered into a database designed to link the clinical information to the biological correlative studies for future analyses. Over the past 5 years there have been 10 clinical trials supported by the Core. These trials have enrolled 1151 subjects, and additional trials are being planned. Currently, 7 trials are actively accruing new subjects. A chemoprevention trial evaluating the activity of lloprost, an oral prostacyclin analogue, was activated during the last grant cycle and will finish accruing subjects in 2007. The success of the core has led to numerous publications. In the last grant year alone 23 peer-reviewed manuscripts have been published. Several manuscripts have been published describing our ability to identify NSCLC patients who will respond to tyrosine-kinase inhibitor therapy and a sentinel manuscript reported on promoter hypermethylation of multiple genes in sputum samples preceeding lung cancer development in our high-risk cohort. Basic researchers have reported on gene expression profiles predicting sensitivity to EGFR inhibitors, as well as a biomarker examination of dysplastic bronchial epithelium for VEGF and c-ErbB1/B2 to gain a better understanding of their potential role as chemopreventive targets. A manuscript describing the association of Ki-67 labeling index with gender and smoking status, but not the presence of lung cancer or COPD, has been accepted, and a manuscript summarizing our experience with sputum cytology and the development of lung cancer has been submitted. In preparation are manuscripts correlating bronchial dysplasia to patient characteristics (arising from numerous SPORE trials) and a manuscript summarizing the results of a chemoprevention trial of 13-cis retinoic acid with or without alpha-tocopherol. Overall, the Colorado Clinical Trials Core has been very productive in translating the science generated from each of the individual projects.