Validation of Biomarkers of Risk for the Early Detection of Lung Cancer

描述(申请人提供)：此EDRN CVC申请是范德比尔特-英格拉姆癌症中心及其附属机构提交的新申请。癌症现在是美国人的头号杀手，肺癌是癌症死亡的头号原因，导致的死亡人数超过乳腺癌、结肠癌和前列腺癌的总和。生物标记物研究专家的这项多学科努力建议将我们和其他机构开发的一套生物标记物进行第二和第三阶段的验证，以具体说明分子签名在评估肺癌诊断和发展肺癌风险方面的临床应用。我们提出了一种三方方法。首先，我们建议在精心设计的病例对照研究中，对在相同标准操作程序下预期收集的现有样本进行诊断候选签名的测试。其次，我们将在一项观察性研究中测试肺癌发展的候选生物标记物，该研究选择了来自纳什维尔社区的非常高风险的个人，对临床、影像(胸部CT)变量以及分子生物标记物特征进行重复测量，其中一些生物标记物特征是通过支气管镜检查获得的。我们的假设是，生物标记物水平的增加与肺癌有关，随着时间的推移，对生物标记物的测量可能会为我们提供比流行病学和影像数据更好的优势，以便及早发现疾病，从而更早地诊断患者，从而导致更多的患者接受手术和明确的干预。第三，我们将按照研究设计和研究参与者授权允许的生物信息库办公室和生物制品研究指南，集中努力收集和存储相关的临床数据和组织(血液、尿液和呼吸道标本)。我们将向社区以及EDRN计划内外的合作者提供这些资源。

DESCRIPTION (provided by applicant): This EDRN CVC application is a new submission by the Vanderbilt-lngram Cancer Center and its affiliated institutions. Cancer is now the number one killer of Americans, and lung cancer is the number one cause of cancer death, causing the deaths of more people than breast, colon, and prostate cancers combined. This multidisciplinary effort of experts in biomarker research proposes to take to phase II and III validation a set of biomarkers developed at our and at other institutions to address specifically the clinical utility of molecular signatures in the assessment of the diagnosis of lung cancer and of the risk of developing lung cancer. We propose a three way approach. First we propose to put diagnostic candidate signatures to the test in carefully designed case-controls studies in existing samples prospectively collected under the same standard operating procedure. Second, we will test candidate biomarkers of lung cancer development in an observational study of selected very high risk individuals from the Nashville community performing repeated measurements of clinical, imaging (chest CT) variables as well as molecular biomarker signatures some of which obtained from bronchoscopic procedures. Our hypothesis is that increased level of the biomarkers is associated with lung cancer and that measurement of the biomarker over time is likely to provide us with an advantage over the epidemiological and imaging data to detect the disease early and therefore to diagnose patients earlier, leading to larger number of patient candidates for surgical and definitive intervention. Third, we will centralize an effort to collect and store pertinent clinical data and tissues (blood, urine, and the airways specimens) following the Office of Biorepositories and Biospecimen Research guidelines as permitted by the study design and research participant authorization. We will make these resources available to the community and to collaborators within and outside of the EDRN program.