Clinical Trials Core

临床试验核心的目标是为SPORE设计和实施的临床试验提供支持 项目调查员。支持包括协助试验准备、监管问题、数据安全和 监督、审计、行为和报告。我们对肺的分子基础的理解不断增加 癌症产生了继续研究的需要，这涉及临床数据和标本的收集 用于分子分析。这种转化方法使我们能够研究肺的生物学途径， 在人体组织中的致癌作用，并已作为一个强有力的工具，在评价新的，生物学原理 预防、筛查和早期发现肺癌的策略。临床试验核心 旨在鼓励基础和临床研究人员之间的互动，以产生关键的翻译 研究临床试验，并提供必要的基础设施，以开发和开展临床研究。 我们在临床试验方法、方案编写、法规文件和质量保证方面提供专业知识 措施通过临床研究中心的合作，建立了一个强大的临床数据库。 试验、组织库和生物统计学/信息学核心，包括收集常见数据元素 （CDE），允许汇总在其他研究中心进行的试验的数据。我们提供临床 研究助理为所有SPORE启动的试验招募受试者并收集数据/组织样本。所有数据都 输入数据库，旨在将临床信息与未来的生物学相关研究联系起来 分析。在过去的5年里，有10项临床试验得到了核心的支持。这些试验 招募了1151名受试者，正在计划进行其他试验。目前，7项审判正在积极积累新的 科目一项评价口服前列环素类似物伊洛前列素活性的化学预防试验， 在上一个赠款周期启动，将于2007年完成累积科目。核心的成功导致了 许多出版物。仅在上一个赠款年度，就出版了23篇同行评议的手稿。 已经发表了几篇文章，描述了我们识别对以下治疗有反应的NSCLC患者的能力： 酪氨酸激酶抑制剂治疗和一份关于多个酪氨酸激酶基因启动子高甲基化的哨兵手稿 在我们的高风险队列中，在肺癌发展之前的痰样本中的基因。基础研究人员 报告了预测EGFR抑制剂敏感性的基因表达谱，以及生物标志物 检查不典型增生的支气管上皮VEGF和c-ErbB 1/B2，以更好地了解其 作为化学预防靶点的潜在作用。描述Ki-67标记指数与 性别和吸烟状况，但不是肺癌或COPD的存在，已经被接受， 总结我们在痰细胞学和肺癌发展方面的经验的一份手稿， 已提交。准备中的是将支气管发育不良与患者特征（由以下因素引起）相关联的手稿 许多SPORE试验）和总结13-顺式维甲酸化学预防试验结果的手稿 含有或不含有α-生育酚的酸。总的来说，科罗拉多临床试验中心在以下方面非常富有成效： 翻译每个项目产生的科学成果。

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.