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

• 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
• 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

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，占所有鳞癌的90%以上。 影响这些组织的癌症(1)。简单地提供普遍的、专家的临床检查不能满足 需要改进口腔/口咽癌的早期诊断。开发和验证一种准确的 评估口腔/口咽癌风险的测试有可能改善治疗结果，减少 相关的发病率，并降低治疗成本。 唾液可溶性CD44(SolCD44)与唾液总蛋白联合检测 警觉生物科学在口腔癌的检测中比传统的更准确 检测技术(5，30，31)此外，SolCD44升高与预后不良独立相关 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、 口腔/口咽癌特异性，基于这些发现的快速护理点(POC)风险评估测试，2) 将此测试方法应用于护理点SolCD44预处理预后测试， 3)探讨SolCD44作为口腔/口咽癌复发风险的动态指标的价值。 在该项目结束时，OncAlert快速概念验证工具包将由一个简单、廉价的护理点组成 口腔/口咽癌风险测试。此外，对脑出血的独立预后价值的确认 SolCD44在口腔/口咽部无复发生存中的应用将形成基础扩大 SolCD44被批准为口腔/口咽癌的预后检测。最后，我们将探讨 SolCD44提供这些癌症的疾病状态的动态指示。