A novel point of care test for oral and oropharyngeal cancer risk

口腔癌和口咽癌风险的新型护理点测试

基本信息

批准号：
10065496
负责人：
Joseph A Califano
金额：
$ 53.09万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-03 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10065496
关键词：
Affect Aftercare Alcohol consumption Biological Assay Biological Sciences CD44 gene Cancer Control Cancer Patient Case-Control Studies Clinical Data Detection Development Devices Disease Disease Outcome Disease-Free Survival Early Diagnosis Environment Frequencies Human Papillomavirus Human papilloma virus infection Incidence Laboratories Malignant Neoplasms Methodology Modeling Morbidity - disease rate Oral Oral Diagnosis Oral cavity Oropharyngeal Performance Populations at Risk Prognosis Prognostic Marker Proteins Recurrence Research Design Risk Risk Assessment Risk Factors Salivary Squamous cell carcinoma Testing Tissues Tobacco use Treatment Cost Validation base cancer risk clinical examination detection method improved industry partner malignant mouth neoplasm malignant oropharynx neoplasm novel outcome prediction point of care point of care testing prognostic assays prognostic value prospective test strip therapy outcome tumor

项目摘要

Squamous cell carcinomas, including those of the mouth and oropharynx, comprise more than 90% of all cancers affecting these tissues (1). Simply providing universal, expert clinical examination would not meet the need for improved early diagnosis of oral/oropharyngeal cancer. Development and validation of an accurate test to assess risk of oral/oropharyngeal cancer has the potential to improve therapeutic outcomes, reduce associated morbidity, and reduce treatment costs. The combination of salivary rinse soluble CD44 (SolCD44) and salivary rinse total protein identified by Vigilant Biosciences has shown to be much more accurate in the detection of oral cancers than conventional detection techniques (5,30,31) In addition, increased SolCD44 is independently associated with poor prognosis in these cancers. This project will 1) continue the development of a unique, stable, inexpensive, noninvasive, easy to use, oral/oropharyngeal cancer specific, rapid point-of-care (POC) risk assessment test based on these findings, 2) develop the application of this testing methodology to a point of care SolCD44 pretreatment prognostic test, and 3) explore the value of SolCD44 as a dynamic indicator of risk of recurrence in oral/oropharyngeal cancer. At the end of this project, the OncAlert rapid POC kit will consist of a simple, inexpensive, point of care test for oral/oropharyngeal cancer risk. In addition, confirmation of the independent prognostic value of SolCD44 in oral/oropharyngeal in recurrence free survival will form the basis for application to expand SolCD44 as an approved prognostic test for oral/oropharyngeal cancer. Finally we will explore the potential for SolCD44 to provide a dynamic indication of disease status in these cancers.

鳞状细胞癌，包括口腔和口咽癌，占所有鳞状细胞癌的 90% 以上影响这些组织的癌症 (1)。仅仅提供普遍的、专家的临床检查并不能满足需要改进口腔/口咽癌的早期诊断。准确的开发和验证评估口腔/口咽癌风险的测试有可能改善治疗结果，减少相关发病率，并降低治疗费用。唾液冲洗液可溶性 CD44 (SolCD44) 和唾液冲洗液总蛋白的组合通过鉴定 Vigilant Biosciences 已证明在口腔癌检测方面比传统方法准确得多检测技术 (5,30,31) 此外，SolCD44 增加与不良预后独立相关在这些癌症中。该项目将 1) 继续开发一种独特的、稳定的、廉价的、非侵入性的、易于使用的、基于这些发现的口腔/口咽癌特异性快速护理点 (POC) 风险评估测试，2) 开发将此测试方法应用于护理点 SolCD44 治疗前预后测试， 3) 探讨 SolCD44 作为口腔/口咽癌复发风险动态指标的价值。在此项目结束时，OncAlert 快速 POC 套件将包括一个简单、廉价的护理点口腔/口咽癌风险测试。此外，确认独立预后价值 SolCD44在口腔/口咽部的无复发生存率将构成扩大应用的基础 SolCD44 作为经批准的口腔/口咽癌预后测试。最后我们将探索潜力 SolCD44 提供这些癌症疾病状态的动态指示。