Multiplexed Paper-Based Blood Test for Early-Stage Colorectal Cancer Screening

用于早期结直肠癌筛查的多重纸质血液检测

基本信息

批准号：
10578142
负责人：
Abraham Badu-Tawiah
金额：
$ 21.55万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-12-26 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10578142
关键词：
3-Dimensional Acids Address African American Air Antibodies Biological Markers Blood Tests Blood specimen CA-125 Antigen Cancer Control Carcinoma Chemicals Clinical Collection Colonoscopy Colorectal Cancer Cryopreservation Detection Development Devices Diagnosis Diagnostic Procedure Disease Disparity Early Diagnosis Eligibility Determination Ensure Enzymes Exclusion Fecal occult blood Feces Fingers Geographic Locations Goals Guaiac Guidelines Heme Hemoglobin Hemorrhage Hispanic Populations Home Hygiene Immunoassay Incidence Income Intestines Investigation Life Low Income Population Low income Malignant Neoplasms Mass Spectrum Analysis Medical Methods Microfluidic Microchips Minority Modernization Monitor Neighborhood Health Center Neoplasms Outcome Paper Pathology Patients Performance Persons Plasma Play Polymers Population Predisposition Preventive Preventive service Proteins Public Health Race Reaction Recommendation Reporting Research Research Project Grants Role Sampling Screening procedure Sensitivity and Specificity Serum Signal Transduction Specific qualifier value Specificity Statistical Algorithm System Techniques Technology Testing Time Tumor Antigens Underserved Population Uninsured United States Vulnerable Populations Whole Blood accurate diagnostics biobank biomarker selection cancer biomarkers cancer care cancer health disparity care systems catalyst colon cancer patients colorectal cancer screening cost design detection platform diagnostic strategy diagnostic value experience improved innovation interest mass spectrometer method development minimally invasive models and simulation mortality multiplex detection novel novel strategies operation outreach outreach program photosystem point of care testing polymerization portability programs protein biomarkers prototype regenerative screening screening program self testing survival outcome underserved community

3-Dimensional Acids Address African American Air Antibodies Biological Markers Blood Tests Blood specimen CA-125 Antigen Cancer Control Carcinoma Chemicals Clinical Collection Colonoscopy Colorectal Cancer Cryopreservation Detection Development Devices Diagnosis Diagnostic Procedure Disease Disparity Early Diagnosis Eligibility Determination Ensure Enzymes Exclusion Fecal occult blood Feces Fingers Geographic Locations Goals Guaiac Guidelines Heme Hemoglobin Hemorrhage Hispanic Populations Home Hygiene Immunoassay Incidence Income Intestines Investigation Life Low Income Population Low income Malignant Neoplasms Mass Spectrum Analysis Medical Methods Microfluidic Microchips Minority Modernization Monitor Neighborhood Health Center Neoplasms Outcome Paper Pathology Patients Performance Persons Plasma Play Polymers Population Predisposition Preventive Preventive service Proteins Public Health Race Reaction Recommendation Reporting Research Research Project Grants Role Sampling Screening procedure Sensitivity and Specificity Serum Signal Transduction Specific qualifier value Specificity Statistical Algorithm System Techniques Technology Testing Time Tumor Antigens Underserved Population Uninsured United States Vulnerable Populations Whole Blood accurate diagnostics biobank biomarker selection cancer biomarkers cancer care cancer health disparity care systems catalyst colon cancer patients colorectal cancer screening cost design detection platform diagnostic strategy diagnostic value experience improved innovation interest mass spectrometer method development minimally invasive models and simulation mortality multiplex detection novel novel strategies operation outreach outreach program photosystem point of care testing polymerization portability programs protein biomarkers prototype regenerative screening screening program self testing survival outcome underserved community

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项目摘要

Project Summary Preventive services have been emphasized as essential components of the medical care system. However, the disparities in cancer incidence and mortality rates experienced by vulnerable populations are evident in rates of screening for colorectal cancer (CRC). While community health centers can play an important role in addressing these disparities, their current operations are not set up to ensure that every eligible patient receives timely CRC screening. The current patient self-test relies on a fecal immunochemical test that is plagued with low rates of positive early cancer identification and difficulty in excluding non-neoplastic causes of intestinal bleed. Until a low-cost, simple, and highly accurate diagnostic method is developed, screening rates in minorities, uninsured, and low-income populations will likely remain low. The long-term goal of this project is to improve the accessibility of CRC screening through the development of a new, on-demand diagnostic approach that has potential to enable self-testing at home followed by signal development and diagnosis after sending the test to a central facility (for example by mail). The objective of the current R21 application is to pre-validate a set of five CRC cancer antigen biomarkers through their multiplexed detection on a 3D paper-based microfluidic device in CRC patients as well as to test the possibility of using a self-regenerative photo-catalyst to amplify mass spectrometry (MS) signals for early CRC detection. The test is designed to be stable enabling storage under ambient conditions, a condition critical for successful remote sampling. The test is also rapid enough to enable point-of- care testing on a portable mass spectrometer. Although the proposed detection strategy is based on immunoassay, the use of a photoredox catalyst to amplify MS signal is novel. Traditional immunoassay tests use colorimetric detection via enzyme amplification, necessitating both cold storage and analysis of the once-initiated colorimetric signal within a specified time to ensure the validity of the test. This research program will follow three specific aims: (1) using 356 CRC patient biorepository samples to validate the five selected biomarkers CEA, CA199, CA242, CA125, CA153 and to optimize their multiplexed detection via paper-based immunoassay, (2) investigation and selection of a photosystem for mass spectrometry signal amplification, and (3) using an independent set of patient samples collected in the field to validate proposed method through the development of a prototype 3D paper-based microfluidic device for CRC detection in whole blood samples. The project is innovative because it combines new levels of simplicity and practicality, modest levels of cost, and a centralized detection strategy, which will redefine the breadth of application and performance/cost ratio for accurate CRC detection in underserved communities. The proposed research is significant because it has potential to improve cancer care among all populations, irrespective of their race, geographic location, or income.

项目摘要预防服务已被强调为医疗系统的重要组成部分。但是，脆弱人群经历的癌症发病率和死亡率差异很明显筛查结直肠癌（CRC）。社区卫生中心可以在解决方面发挥重要作用这些差异，他们当前的操作尚未建立以确保每个合格的患者及时收到CRC 筛选。当前的患者自我测试依赖于粪便免疫化学测试，该测试困扰着低率早期癌症阳性鉴定和排除肠道出血的非肿瘤原因的困难。直到a 开发了低成本，简单且高度准确的诊断方法，少数民族的筛查率，未保险，低收入人群可能会保持较低。该项目的长期目标是改善可访问性通过开发一种新的按需诊断方法来筛选CRC筛查，该方法有可能在将测试发送到中央后，在家中进行自我测试，然后进行信号开发和诊断设施（例如，通过邮件）。当前R21应用的目的是预验证一组五个CRC 癌症抗原生物标志物通过在CRC中的3D纸基微流体装置上的多重检测患者以及测试使用自我再生光催化剂扩增质谱法的可能性（MS）早期CRC检测的信号。该测试的设计是稳定的，在环境下启用存储条件，这对于成功的远程抽样至关重要。该测试也足够快，可以实现在便携式质谱仪上进行护理测试。尽管拟议的检测策略是基于免疫测定，使用光氧催化剂来扩增MS信号是新颖的。传统的免疫测试使用通过酶扩增比色检测，需要冷藏和分析曾经发射的在指定的时间内进行比色信号，以确保测试的有效性。该研究计划将遵循三个具体目的：（1）使用356个CRC患者生物座席样品验证五个选定的生物标志物CEA， CA199，CA242，CA125，CA153，并通过基于纸张的免疫测定法优化其多路复用检测，（2）调查和选择用于质谱信号放大的光系统，（3）使用在现场收集的独立的患者样品集，以通过开发来验证提出的方法用于全血样品中CRC检测的原型3D纸基微流体设备的原型。该项目是创新的，因为它结合了新的简单性和实用性，适度的成本水平，并且是集中的检测策略，这将重新定义准确CRC的应用和性能/成本比的广度在服务不足的社区中的检测。拟议的研究很重要，因为它具有改进的潜力所有人群中的癌症护理，无论其种族，地理位置或收入如何。