Salivary Soluble Markers in Head and Neck Cancer

描述（申请人提供）：头颈部鳞状细胞癌（HNSCC）是一种毁灭性的疾病，全球每年有50万例新发癌症病例。只有50%的HNSCC患者被治愈，很大程度上是因为大多数癌症是在晚期被诊断出来的。这一挑战在黑人患者中比在白人患者中更为明显，在经济弱势人群中比在富裕人群中更为明显。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。它们以可溶性形式存在，可在口腔冲洗液中检测到，并可通过简单廉价的ELISA或ELISA样测定法测定。我们的主要目的是评估由可溶性CD44， HA和HAase组成的标记面板在区分侵袭性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Specific Aim 1中，我们确定了口腔冲洗液中solCD44、HA和HAase水平是否能够以良好的敏感性和特异性区分新诊断的侵袭性HNSCC患者和高危对照者。在特异性目标2中，我们评估了对照组和HNSCC患者口腔冲洗液中solCD44、HA和HAase水平的短期变异性。我们的长期目标是设计并实施一项明确的筛查试验，其结果是早期发现，最明确的是，生存。这一项目与保健社区的需要有关，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口，即少数民族和经济上处于不利地位的人。

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.