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，每年在全球范围内造成50万新的癌症病例。只有50%的HNSCC患者被治愈，这在很大程度上是因为大多数癌症是在晚期诊断出来的。与白人患者相比，这一挑战在黑人患者中更加明显，与富裕人群相比，经济困难人群的挑战更为明显。需要对HNSCC进行更好的诊断测试。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，可在口腔漱口液中检测到，并可通过简单且廉价的酶联免疫吸附试验或类似的酶联免疫吸附试验进行测定。我们的主要目的是评估由可溶性CD44、HA和HAASE组成的标记物组合在区分侵袭性HNSCC患者和对照组方面的准确性。为了做到这一点，我们将使用病例对照研究设计，并将追求以下具体目标。在特定的目标1中，我们确定口腔漱口水中solCD44、HA和HAase的水平是否具有良好的敏感性和特异性来区分新诊断的侵袭性HNSCC患者和高危对照患者。在特定目标2中，我们评估了对照组和HNSCC患者口腔含漱液中solCD44、HA和HAase水平的短期变异性。我们的长期目标是设计和实施一项确凿的筛查试验，结果是早期发现，最确定的是生存。该项目与卫生保健界的需求相关，因为它为我们实现长期目标迈出了第一步，并包括了最需要改进检测的人群，即少数群体和经济上处于不利地位的人群。

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.