Salivary Soluble Markers in Head and Neck Cancer

描述（由申请人提供）：头颈部鳞状细胞癌（HNSCC）是一种毁灭性疾病，每年全球有50万例新发癌症病例。只有50%的HNSCC患者被治愈，这主要是因为大多数癌症都是在晚期被诊断出来的。与白色患者相比，这种挑战在黑人患者中更为明显，与富裕人群相比，经济上处于不利地位的人群更为明显。需要更好的HNSCC诊断测试。CD44、透明质酸（HA）和透明质酸酶（HAase）是参与肿瘤发生过程的相关分子。它们以可溶形式存在，在口腔冲洗液中可检测到，并通过简单且廉价的ELISA或ELISA样测定法进行测量。我们的主要目的是评估由可溶性CD44、HA和HAase组成的标志物组在区分侵袭性HNSCC患者和对照组中的准确性。为此，我们将采用病例对照研究设计，并将追求以下具体目标。在具体目标1中，我们确定口腔冲洗液中的solCD44、HA和HAase水平是否以有利的灵敏度和特异性区分新诊断的侵袭性HNSCC患者和高风险对照。在具体目标2中，我们评估了来自对照和HNSCC患者的口腔冲洗液中solCD44、HA和HAase水平的短期变异性。我们的长期目标是设计和执行一个明确的筛查试验，结果是早期发现和最明确的生存。该项目与卫生保健界的需求有关，因为它为实现我们的长期目标迈出了第一步，并包括最需要改进检测的人群，即少数民族和经济弱势群体。

DESCRIPTION (provided by applicant): Head and neck squamous cell carcinoma (HNSCC) is a devastating disease accounting for 500,000 new cancers cases worldwide each year. Only 50% of patients with HNSCC are cured, largely because the majority of cancers are diagnosed in late stage. This challenge is more pronounced in black patients compared to white patients and economically disadvantaged populations compared to wealthy populations. Better diagnostic tests for HNSCC are needed. CD44, hyaluronic acid (HA) and hyaluronidase (HAase) are related molecules involved in the process of tumorigenesis. They exist in soluble form, are detectable in oral rinses, and are measured by simple and inexpensive ELISA or ELISA-like assays. Our main objective is to evaluate the accuracy of a marker panel comprised of soluble CD44, HA and HAase in distinguishing between patients with invasive HNSCC and controls. To do this we will use a case-control study design and will pursue the following Specific Aims. In Specific Aim 1 we determine whether solCD44, HA and HAase levels in oral rinses distinguish between patients with newly diagnosed, invasive HNSCC and high-risk controls with favorable sensitivity and specificity. In Specific Aim 2 we assess short-term variability of solCD44, HA, and HAase levels in oral rinses from control and HNSCC patients. Our long-term goal is to design and perform a definitive screening trial with the outcomes of early detection and most definitively, survival. This project is relevant to the needs of the health care community because it provides the first step towards our long-term goal, and includes the populations most in need of improved detection, namely minorities and the economically disadvantaged.