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

鳞状细胞癌，包括口腔和口咽的鳞状细胞癌，占所有恶性肿瘤的90%以上。 影响这些组织的癌症（1）。仅仅提供普遍的专家临床检查并不能满足 需要改进口腔/口咽癌的早期诊断。开发和验证一个准确的 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，并降低治疗费用。 唾液冲洗液可溶性CD 44（SolCD 44）和唾液冲洗液总蛋白的组合通过免疫组织化学法鉴定。 Vigilant Biosciences已经证明在检测口腔癌方面比传统的更准确 检测技术（5，30，31）此外，SolCD 44增加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、稳定、廉价、非侵入性、易于使用， 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） 开发该测试方法在护理点SolCD 44预处理预后测试中的应用， 探讨SolCD 44作为口腔/口咽癌复发风险动态指标的价值。 在该项目结束时，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，证实独立的预后价值， SolCD 44在口腔/口咽中的无复发生存率将成为扩大应用的基础。 SolCD 44作为口腔/口咽癌的批准预后测试。最后，我们将探讨 Sol ⑶ 44以提供这些癌症中疾病状态的动态指示。

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.