Translating buccal nanocytology for lung cancer screening into clinical practice

将口腔纳米细胞学肺癌筛查转化为临床实践

• 批准号: 9539327
• 负责人: Vadim Backman
• 金额: $ 63.85万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9539327
• 关键词: Address; Age; American; Architecture; Area; Biological Markers; Biophotonics; Blinded; Boston; Bronchoscopy; Cancer Etiology; Cancer Patient; Cells; Cessation of life; Cheek structure; Chromatin; Chromatin Structure; Clinical; Clinical Data; Clinical Research; Clinical Trials; Consultations; Data; Death Rate; Development; Diagnosis; Diagnostic; Disease; Early Diagnosis; Electron Microscopy; Ensure; Esophageal; Excision; Gender; Genetic; Goals; Grant; Heterogeneity; Individual; Laboratories; Lead; Lesion; Life; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Medical Device; Medical center; Microscopy; Molecular; Mucous Membrane; Nuclear; Operative Surgical Procedures; Optics; Oral mucous membrane structure; Patients; Population; Prevalence; Procedures; Protocols documentation; ROC Curve; Risk; Risk stratification; Sampling; Savings; Sensitivity and Specificity; Smoke; Smoker; Smoking History; Specificity; Swab; Techniques; Technology; Testing; Time; Translating; Validation; X-Ray Computed Tomography; base; cancer subtypes; candidate marker; carcinogenesis; case control; clinical practice; computed tomography screening; cost; cost effective; demographics; diagnostic accuracy; disease diagnosis; improved; industry partner; instrumentation; interest; low-dose spiral CT; lung cancer screening; lung carcinogenesis; minimally invasive; nanoarchitecture; nanocytology; nanoscale; novel; patient stratification; patient subsets; prevent; primary care setting; screening; technology development; tool; tumor

Project Summary The overarching goal of the Academic Industrial Partnership grant is to develop a population risk-stratification tool that will allow efficacious and cost-effective lung cancer screening. Lung cancer represents an ideal malignancy for screening because of its prevalence, identifiable risk groups (current/former smokers) and ability to surgically cure the disease if diagnosed early. However, there are no robust screening techniques with options such as low-dose CT (LDCT) scans fraught with cost and harm from large numbers of false positives. In order to make lung cancer screening viable, it is imperative to develop a test to pre-screen for LDCT by identifying the subset of patients who are likely to harbor lung cancers and would benefit from LDCT. The test must be sensitive to early disease (e.g. Stage I), low-cost, and able to be carried out in a primary care setting. The goal of this project is to develop such a test. One attractive approach is to exploit field carcinogenesis, the concept that the same genetic/environmental milieu that results in a lesion in one area of the lung will impact upon the entire aero digestive mucosa. The buccal (cheek) mucosa is a “molecular mirror” of lung carcinogenesis, although current techniques are inadequate to translate this phenomenon into a minimally intrusive screening test. The preliminary data show that the alteration of nanoscale architecture in buccal cells is exquisitely sensitive to field carcinogenesis and hence may serve as a robust biomarker for lung cancer. These nano-architectural changes can be detected in a practical and highly accurate fashion via a novel biophotonics technology, partial wave spectroscopic (PWS) microscopy (“nanocytology”). In this study, PWS technology will be refined and a prediction rule developed based on the PWS-detectable nanoscale alterations that is optimized for early stage, curable lung cancer. The goal of the proposed project is to finalize the remaining technology development aspects to translate nanocytology into a practical, accurate, and low- cost test, bring it to the point where it is viable for population screening, and conduct a pre-definitive clinical validation. The team envision that upon completion of this project, nanocytology will be ready for a definitive clinical trial leading to a launch in clinical practice. This novel paradigm could transform the clinical practice of lung cancer screening and thereby mitigate the large toll of this malignancy in Americans.

项目概要 学术工业合作伙伴赠款的总体目标是制定人口风险分层 该工具将允许有效且具有成本效益的肺癌筛查。肺癌代表一种理想 由于其患病率、可识别的风险群体（当前/以前吸烟者）和 如果及早诊断，能够通过手术治愈该疾病。但目前尚无可靠的筛查技术 诸如低剂量 CT (LDCT) 扫描之类的选项充满了成本和大量虚假信息带来的危害 积极的一面。为了使肺癌筛查可行，必须开发一种测试来预先筛查肺癌 LDCT 通过识别可能患有肺癌并可从 LDCT 中受益的患者子集来进行。 该测试必须对早期疾病（例如第一阶段）敏感、成本低并且能够在初级保健中进行 环境。该项目的目标是开发这样的测试。一种有吸引力的方法是利用领域 致癌作用是指相同的遗传/环境环境导致某一区域出现病变的概念 肺部会影响整个空气消化粘膜。颊（脸颊）粘膜是一面“分子镜” 尽管目前的技术不足以将这种现象转化为肺癌发生的原因 最小侵入性筛查测试。初步数据表明，纳米结构的改变 口腔细胞对现场癌变非常敏感，因此可以作为肺部的强有力的生物标志物 癌症。这些纳米结构的变化可以通过实用且高度准确的方式检测到 新颖的生物光子技术，部分波谱（PWS）显微镜（“纳米细胞学”）。在这项研究中， PWS技术将得到完善，并基于PWS可检测的纳米尺度开发预测规则 针对早期可治愈肺癌进行优化的改变。拟议项目的目标是最终确定 剩下的技术开发方面将纳米细胞学转化为实用、准确和低成本的技术 成本测试，使其达到可用于人群筛查的地步，并进行预先确定的临床 验证。该团队预计，该项目完成后，纳米细胞学将准备好进行最终的研究。 临床试验导致临床实践的启动。这种新颖的范例可以改变临床实践 肺癌筛查，从而减轻美国人因这种恶性肿瘤造成的巨大死亡。