RAPID System for Early Detection of Head and Neck Cancer in Low-Resource Settings

用于资源匮乏地区早期检测头颈癌的 RAPID 系统

• 批准号: 10444593
• 负责人: WALTER Tsong LEE
• 金额: $ 56.01万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10444593
• 关键词: 3D Print; Address; Area; Biological Assay; Biological Markers; Biological Models; Biopsy; Cancer Detection; Cancer Diagnostics; Caring; Clinic; Clinical; Communities; Cytology; DNA; Data Analyses; Detection; Developing Countries; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic Services; Disease; Distant Metastasis; Early Diagnosis; Early treatment; Evaluation; FDA approved; Fresh Tissue; Goals; Head and Neck Cancer; Head and neck structure; Health Personnel; Healthcare; High Prevalence; Histology; Hospitals; Hour; Human Papillomavirus; Human Resources; Human papilloma virus infection; Individual; Infrastructure; Knowledge; Laboratories; Learning; Lesion; Liquid substance; Low income; Malignant Neoplasms; Malignant neoplasm of thyroid; Medical; Messenger RNA; Methods; Molecular; Molecular Analysis; Morbidity - disease rate; Operative Surgical Procedures; Output; Pathology; Patients; Point of Care Technology; Polymerase Chain Reaction; Preparation; Quantitative Reverse Transcriptase PCR; RNA; Rapid screening; Reader; Reagent; Research; Resource-limited setting; Resources; Risk Factors; Sampling; Screening for cancer; Screening procedure; Smoking; Specificity; Squamous cell carcinoma; Stains; Surface; System; Techniques; Technology; Testing; Tissue Sample; Training; Translations; Treatment outcome; Underserved Population; Validation; Work; accurate diagnosis; anticancer research; base; cancer type; clinical care; clinical translation; community setting; convolutional neural network; cost; design; diagnostic accuracy; diagnostic platform; diagnostic technologies; diagnostic tool; equipment training; global health; health application; hospital laboratories; instrument; instrumentation; magnetic beads; miniaturize; molecular marker; mortality; multiplex assay; multiplex detection; multiplex diagnostics; nanophotonic; nanoplasmonic; new technology; novel; plasmonics; point of care; point-of-care diagnosis; point-of-care diagnostics; portability; rapid detection; rapid diagnosis; screening; technology validation; underserved community

Due to the high prevalence of risk factors such as smoking and human papillomavirus infection, head and neck cancers are a particular threat to individuals in low-income, underserved communities. Because of limited access to screening tools for early cancer detection to reduce mortality and morbidity, they have diminishing chances of long-term survival. Cancer mortality and morbidity in these areas will not see a reduction without the development of practical and easily accessible diagnostic methods and instrumentation. To address these limitations, we propose to develop and validate a nanophotonics-enhanced molecular assay based on ultrabright surface-enhanced Raman scattering (SERS) “nanorattle” probes for multiplexed detection of biomarkers of squamous cell carcinoma; this cancer accounts for about 85% of all head and neck cancers. For analytical validation, our assay method will be tested on clinical samples, such as fresh tissue and brush cytology biopsies. Brush cytology is a form of non-invasive biopsy performed without the need of surgical or specialized care. By combining “lab-on-a-stick” technology with ultrabright SERS nanorattles, the assay concept provides a unique rapid ‘sample-to-answer’ approach. Our molecular analysis technology is designed to be integrated in a portable device, referred to as Raman Assay using Plasmonics for Identification and Diagnosis (RAPID). We envision the RAPID technology to be deployed as a low-cost diagnostic tool capable of point-of- care head and neck cancer identification, with the potential to reduce the morbidity and mortality of this disease in underserved populations due to early detection of cancer. The project’s aims are the following: (1) Develop nanoplasmonic-based nanorattle probes for multiplex detection of head and neck cancer molecular biomarkers; (2) Integrate the molecular analysis method into a simple-to-use, automated and portable point-of-care device; (3) Evaluate and validate the molecular analysis method for diagnosis in tissue samples and brush cytology biopsies; and (4) Deploy the technology for implementation at the point-of-care in an underserved community setting. The implications of the RAPID method are vast and significant for cancer research as well as diagnostics, especially in the setting of underserved populations. For patients presenting with a suspicious head and neck lesion, our method can provide a rapid diagnosis, allowing for earlier treatment before the onset of distant metastases. This novel technology will also allow direct mRNA biomarker detection for research on cancer development and progression. Compared to laboratory-based histopathologic diagnosis, requiring specialized equipment and trained operators for qRT-PCR and often taking weeks or even months in remote regions, the RAPID method can be completed in less than an hour at the point of need. Ultimately, the integration of this molecular method into a portable device will allow for clinical translation to render a faster and more accurate diagnosis at point-of-care settings and for global health applications.

由于吸烟和人乳头瘤病毒感染等危险因素的高流行率， 对于低收入、得不到充分服务的社区的个人来说，颈部癌症是一个特别的威胁。由于有限的 获得早期癌症检测的筛查工具以降低死亡率和发病率， 长期生存的机会。如果不采取措施，这些地区的癌症死亡率和发病率就不会下降。 开发实用且易于使用的诊断方法和仪器。 为了解决这些局限性，我们建议开发和验证纳米光子增强的分子测定 基于超亮表面增强拉曼散射（Sers）“纳米阵列”探针进行多路检测 鳞状细胞癌的生物标志物;这种癌症占所有头颈部癌症的约85%。 为了进行分析验证，我们的分析方法将在临床样本上进行测试，例如新鲜组织和刷子 细胞学活检。刷检细胞学是一种非侵入性活检，无需手术或 专业护理。通过将“棒上实验室”技术与超亮Sers纳米塔相结合， 提供了一种独特的快速“从样本到答案”的方法。我们的分子分析技术旨在 集成在便携式设备中，称为使用等离子体的拉曼分析，用于识别和诊断 （快速）。我们设想将RAPID技术作为一种低成本的诊断工具部署， 护理头颈部癌症的识别，有可能降低这种疾病的发病率和死亡率 因为癌症的早期发现， 本项目的目标如下：（1）开发基于纳米等离子体的纳米阵列探针， 头颈癌分子生物标志物的检测;（2）将分子分析方法整合到一个 使用简单、自动化和便携式护理点设备;（3）评估和验证分子分析 组织样本和刷检细胞学活检的诊断方法;以及（4）部署该技术， 在服务不足的社区环境中的护理点实施。 RAPID方法的意义是巨大的，对癌症研究和诊断都很重要， 特别是在服务不足的人群中。对于头部和颈部可疑的患者 病变，我们的方法可以提供一个快速的诊断，允许早期治疗之前发生的遥远 转移这项新技术也将允许直接mRNA生物标志物检测用于癌症研究 发展和进步。与基于实验室的组织病理学诊断相比， qRT-PCR的设备和训练有素的操作人员，在偏远地区通常需要数周甚至数月， RAPID方法可以在需要时在不到一小时内完成。最终， 将分子方法转换为便携式设备将允许临床翻译，以提供更快，更准确的 在护理点的诊断设置和全球健康应用。