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

描述（由申请人提供）：本EDRN CVC申请是由Vanderbilt-lngram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了乳腺癌、结肠癌和前列腺癌的总和。生物标志物研究专家的多学科努力建议将我们和其他机构开发的一组生物标志物进行II期和III期验证，以专门解决分子特征在肺癌诊断评估和肺癌发展风险中的临床应用。我们建议采取三管齐下的办法。首先，我们建议将诊断候选签名放入精心设计的病例对照研究中，在相同的标准操作程序下前瞻性地收集现有样本。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志物，该研究选择了来自纳什维尔社区的高危个体，对临床、成像（胸部CT）变量以及分子生物标志物特征进行重复测量，其中一些数据来自支气管镜检查。我们的假设是，生物标志物水平的升高与肺癌有关，随着时间的推移，生物标志物的测量可能会为我们提供比流行病学和影像学数据更有利的优势，从而早期发现疾病，从而更早地诊断患者，从而导致更多的患者接受手术和最终干预。第三，我们将集中收集和储存相关的临床数据和组织（血液、尿液和气道标本），按照研究设计和研究参与者授权允许的生物储存库和生物标本研究办公室指南。我们将把这些资源提供给社区以及EDRN项目内外的合作者。

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.