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

肺癌早期检测风险生物标志物的验证

• 批准号: 9463350
• 负责人: PIERRE P. MASSION
• 金额: $ 71.13万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-16 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9463350
• 关键词: Address; Area; Assessment tool; Autoantibodies; Benign; Biodistribution; Biological; Biological Markers; Blood; Bronchoscopy; Caliber; Cancer Etiology; Cessation of life; Characteristics; Clinical; Clinical Data; Collaborations; Communities; Computer software; Country; Data Set; Development; Diagnosis; Diagnostic; Disease; Dose; Early Detection Research Network; Early Diagnosis; Evaluation; Funding; Glutamates; Goals; Human; Image; Imaging Device; Imaging technology; Individual; Institution; Investigation; Label; Lead; Lung nodule; Malignant - descriptor; Malignant neoplasm of lung; Measurement; Measures; MicroRNAs; Military Personnel; Modeling; Molecular; Molecular Profiling; National Cancer Institute; Nested Case-Control Study; Nodule; Observational Study; Oxidative Stress; Paper; Patient Care; Patient Recruitments; Patients; Phase; Population; Positron-Emission Tomography; Prospective Studies; Prospective cohort; Prospective cohort study; Pulmonary Mass; RNA; Research; Research Design; Resources; Risk; Risk Assessment; Screening for cancer; Specimen; Sputum; System; Testing; Time; Tissues; Tracer; Urine; Validation; Work; biobank; biomarker development; biomarker evaluation; biomarker validation; bronchial epithelium; cancer biomarkers; candidate marker; chest computed tomography; clinical decision-making; clinical predictors; cohort; complement C4d; computed tomography screening; design; diagnostic accuracy; diagnostic biomarker; disorder risk; early detection biomarkers; high risk; imaging biomarker; imaging probe; improved; in vivo; industry partner; interdisciplinary approach; lung cancer screening; molecular imaging; molecular marker; multidisciplinary; novel; predictive modeling; programs; prospective; public health relevance; rate of change; recruit; screening; standard of care; tool; tumor; tumor DNA; validation studies

 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.

 描述（由申请人提供）：生物标志物研究专家的这一多学科努力旨在重申他们对EDRN的承诺，并带领我们的临床验证中心更接近影响患者护理。因此，我们建议测试我们和其他机构开发的肺癌最佳候选生物标志物，以增加与标准治疗相比评估肺癌风险和诊断的价值。该假设是，通过胸部计算机断层扫描以及痰液、支气管上皮和血液中测量的成像和分子生物标志物的添加，可能以多变量的方式，可以提高肺癌高危个体的识别，并通过减少假阳性测试来改善CT筛查的总体结果。我们提出了三种方法。首先，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极高风险个体，对临床、成像（低剂量胸部CT）变量以及分子生物标志物特征进行重复测量，其中一些将从支气管镜检查中获得。其次，我们建议在精心设计的前瞻性研究中，对不确定的肺结节患者进行每项测试，以验证最有希望的诊断候选签名。第三，我们将在中高危肺结节人群中测试一种新型分子成像示踪剂。该示踪剂将与护理标准FDG PET进行比较，如果明显更好，则应该对肺结节的管理产生巨大影响。我们的CVC还将集中精力收集和存储相关的临床数据和组织（血液、尿液和气道标本），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。