Clinical validation of the HD-CTC fluid biopsy in early detection of lung cancer.

HD-CTC 液体活检在肺癌早期检测中的临床验证。

基本信息

批准号：
8625205
负责人：
PETER KUHN
金额：
$ 47.63万
依托单位：
SCRIPPS RESEARCH INSTITUTE, THE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-20 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8625205
关键词：
Advanced Development Biological Assay Biological Markers Biology Biopsy Blood Tests Cancer Histology Caring Cells Characteristics Clinic Clinical Clinical Data Clinical Research Data Detection Development Diagnosis Diagnostic Disease Emerging Technologies Enrollment Epithelial Cells Evaluation Fluorescent in Situ Hybridization Genome Genomics Image Investigation Liquid substance Lung nodule Malignant - descriptor Malignant Neoplasms Malignant neoplasm of lung Malignant neoplasm of pancreas Malignant neoplasm of prostate Measures Medical Methods Modeling Molecular Molecular Analysis Morphology Neoplasm Circulating Cells Neoplasm Metastasis Nodule Non-Malignant Non-Small-Cell Lung Carcinoma Operative Surgical Procedures Outcome Pathologic Patients Performance Phase Positron-Emission Tomography Procedures Process Prospective Studies Proteins Publishing Recurrence Relative (related person)Research Design Sampling Specificity Staging Staging System System Techniques Technology Testing Time Tissues Translations Tumor Biology United States National Institutes of Health Validation Venous blood sampling anticancer research case control clinical Diagnosis clinically relevant cohort cost effective design disease characteristic disorder subtype expectation imaging modality immunocytochemistry improved in vivo in vivo Model insight lung cancer screening malignant breast neoplasm outcome forecast performance tests prognostic public health relevance response standard of care tool translational study tumor tumor metabolism tumor progression

项目摘要

DESCRIPTION (provided by applicant): Currently, the clinical diagnosis of non-small cell lung cancer (NSCLC) relies on a number of imaging modalities followed by a tissue confirmation with an invasive procedure. This process is somewhat imprecise because a patient's pathologic diagnosis after surgery may be discordant from pre-operative assessment and may contribute to poor patient prognosis since accurately staging early cancers is essential to good outcome. We hypothesize that rigorously validating the recently developed High Definition Circulating Tumor Cell (HD- CTC) Fluid Biopsy in a controlled clinical cohort of patients undergoing evaluation for lung cancer will improve the accuracy of detection and prognosis in early-stage, malignant nodules of the lung with non-small cell lung cancer histology. We will capitalize on NIH-supported proof of concept data, which has demonstrated that the HD-CTC Fluid Biopsy is capable of detecting disease derived cells in the majority of patients at the time of diagnosis. These data now motivate us to investigate the performance of the assay "the day before diagnosis" with the expectation of achieving similar results in a more realistic, prospectively designed, clinical study with matched controls consisting of patients who have non-malignant lung nodules. Our aim is to accurately establish the test characteristics of the HD-CTC fluid biopsy in a group of patients undergoing evaluation for lung cancer and to identify those patients with malignant nodules that have detectable HD-CTCs to determine whether the fluid biopsy can augment 1) clinical staging prior to definitive treatment and 2) prognosis after definitive diagnosis and treatment. We will significantly enhance the test by developing single cell molecular analysis to provide definitive characterization. Integrating non-invasive, reliable and accurate circulating biomarkers with the current standard of care will not only allow for the development of more accurate clinical prediction models that are cost-effective, but may also augment our understanding of tumor biology and metastasis using a clinical, in vivo model of early non-small cell lung cancer.

描述（由申请人提供）：目前，非小细胞肺癌（NSCLC）的临床诊断依赖于多种成像方式，然后通过侵入性手术进行组织确认。这个过程有些不精确，因为患者术后的病理诊断可能与术前评估不一致，并且可能导致患者预后不良，因为准确分期早期癌症对于良好的结果至关重要。我们假设，在接受肺癌评估的受控临床患者队列中严格验证最近开发的高清循环肿瘤细胞（HD-CTC）液体活检将提高早期肺部恶性结节的检测和预后的准确性具有非小细胞肺癌组织学特征。我们将利用 NIH 支持的概念验证数据，该数据证明 HD-CTC 流体活检能够在诊断时检测大多数患者的疾病衍生细胞。这些数据现在激励我们在“诊断前一天”研究该检测的性能，期望在一项更现实的、前瞻性设计的临床研究中获得类似的结果，该研究具有由非恶性肺结节患者组成的匹配对照。我们的目标是在一组接受肺癌评估的患者中准确建立 HD-CTC 液体活检的测试特征，并识别那些具有可检测到 HD-CTC 的恶性结节患者，以确定液体活检是否可以增强 1)明确治疗前的临床分期和 2) 明确诊断和治疗后的预后。我们将通过开发单细胞分子分析来显着增强测试，以提供明确的表征。将非侵入性、可靠且准确的循环生物标志物与当前的护理标准相结合，不仅可以开发出更具成本效益的更准确的临床预测模型，而且还可以利用临床、早期非小细胞肺癌的体内模型。