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: 8721348
• 负责人: PIERRE P. MASSION
• 金额: $ 59.85万
• 依托单位: VANDERBILT UNIVERSITY
• 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 2016-04-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8721348
• 关键词: Address; American; Authorization documentation; Biological; Biological Markers; Biopsy; Blood; Bronchoscopy; Cancer Center; Cancer Detection; Cancer Etiology; Case-Control Studies; Cause of Death; Cessation of life; Chest; Clinical; Clinical Data; Cohort Studies; Colon Carcinoma; Communities; Country; Cytogenetics; Data; Detection; Development; Diagnosis; Diagnostic; Disease; Doctor of Medicine; Dose; Early Detection Research Network; Early Diagnosis; Epidemiology; Evaluation; Gene Expression Profile; General Population; Goals; Guidelines; Image; Imaging technology; Individual; Institution; Intervention; Lead; Lung; Lung nodule; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of prostate; Measurement; Measures; MicroRNAs; Molecular; Molecular Profiling; Observational Study; Operative Surgical Procedures; Outcome Study; Participant; Patients; Phase; Population; Procedures; Proteomics; Research; Research Design; Research Personnel; Resources; Risk; Risk Assessment; Sampling; Shapes; Specimen; Staging; Testing; Time; Tissues; Urine; Validation; airway epithelium; biobank; cancer risk; case control; cohort; design; high risk; lung cancer screening; malignant breast neoplasm; multidisciplinary; programs; prospective; screening; tool

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.

描述（由申请人提供）：此EDRN CVC申请是Vanderbilt-Lngram癌症中心及其附属机构的新提交。癌症现在是美国人的头号杀手，肺癌是癌症死亡的第一起，导致死亡人数比乳腺癌，结肠和前列腺癌的死亡人数更多。生物标志物研究专家的这一多学科工作建议在我们和其他机构中开发的一系列生物标志物，以解决分子特征的临床实用性，以评估肺癌诊断以及患肺癌的风险。我们提出了三种方法。首先，我们建议将诊断候选签名放在测试中，以在同一标准操作程序中前瞻性收集的现有样本中精心设计的病例对照研究中进行测试。其次，我们将测试肺癌发展的候选生物标志物在一项对纳什维尔社区所选的非常高风险个体的观察性研究中，对临床，成像（胸部CT）变量的重复测量以及分子生物标志物签名进行了重复测量，其中一些是从支气管镜手术中获得的。我们的假设是，生物标志物的水平提高与肺癌有关，并且随着时间的推移，生物标志物的测量可能使我们比流行病学和成像数据具有优势，以尽早检测疾病，因此可以及早诊断患者，从而导致大量的手术和确定性干预患者数量。第三，我们将努力在研究设计和研究参与者授权的允许的情况下，在生物局和生物循环研究指南办公室收集和存储相关的临床数据和组织（血液，尿道和气道标本）。我们将向社区和EDRN计划内外的合作者提供这些资源。