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

 描述(由申请人提供)：生物标记物研究专家的这一多学科努力建议重申他们对EDRN的承诺，并领导我们的临床验证中心更接近于影响患者护理。因此，我们建议测试我们和其他机构开发的最佳候选肺癌生物标记物在评估和诊断肺癌风险方面的附加值，并与护理标准进行比较。这个假设是，通过胸部计算机断层扫描以及痰、支气管上皮和血液中测量的成像和分子生物标记物的增加，可能以多变量的方式，可以改善肺癌高危个体的识别，并通过减少假阳性测试来改善CT筛查的整体结果。我们提出了一种三方方法。首先，我们将在一项观察性研究中测试肺癌发生的候选生物标记物，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(低剂量胸部CT)变量以及分子生物标记物签名进行重复测量，其中一些将通过支气管镜检查获得。其次，我们建议在精心设计的对出现不确定肺结节的个体进行的前瞻性研究中，验证每项测试中最有希望的诊断候选签名。第三，我们将在中高风险肺结节人群中测试一种新的分子成像示踪剂。这种示踪剂将与标准护理FDG PET进行比较，如果明显更好，应该会对肺结节的管理产生巨大影响。我们的CVC还将集中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)，并将这些资源提供给社区和EDRN计划内外的合作者，包括行业合作伙伴。

 DESCRIPTION (provided by applicant): This multidisciplinary effort of experts in biomarker research proposes to renew their commitment to the EDRN and to lead our Clinical Validation Center ever closer to impacting patient care. Therefore we propose to test best candidate biomarkers of lung cancer developed at our and other institutions for added value in the assessment of the risk for, and diagnosis of, lung cancer compared to the standard of care. The hypothesis is that addition of imaging and molecular biomarkers measured by chest computed tomography and in the sputum, the bronchial epithelium and blood, likely in a multivariable manner, could improve the identification of high risk individuals for lung cancer and improve CT screening overall results by reducing false-positive tests. We propose a three way approach. First we will test candidate biomarkers for lung cancer development in an observational study of selected very high risk individuals from the Nashville community performing repeated measurements of clinical, imaging (low-dose chest CT) variables, as well as molecular biomarker signatures, some of which will be obtained from bronchoscopy. Second, we propose to validate the most promising diagnostic candidate signatures to each test in carefully designed prospective study of individuals presenting with indeterminate pulmonary nodules. Third, we will test a novel molecular imaging tracer in a population of intermediate and high risk lung nodules. This tracer will be compared to standard of care FDG PET, and if significantly better, should have huge impact on the management of lung nodules. Our CVC will also centralize an effort to collect and store pertinent clinical data and tissues (blood, urine, and the airways specimens) and make these resources available to the community and to collaborators within and outside of the EDRN program, including the industry partners.