Plasma and saliva biomarkers of disease status in HPV related oropharynx cancer

人乳头瘤病毒(HPV)相关口咽癌(HPVOPC)在美国呈上升趋势，现在 超过了宫颈癌的发病率。复发的HPVOPC患者在以下情况下存活率有所提高 与HPV阴性的OPC患者相比，这些患者中的大多数都有机会持久 疾病控制。总体而言，这些数据意味着对HPVOPC复发疾病的有效早期检测 患者提供了一个有效挽救复发/转移性疾病患者的机会。 最近的研究表明，血浆或唾液中的HPV16DNA可以作为一种标志物 HPVOPC中的疾病，以及从检测到复发到临床可能有足够的提前时间 对唾液和/或血浆中存在HPV16DNA的患者进行干预。因此，我们开发了一部小说， CLIA认证临床实验室的HPV16DNA基因组唾液/血浆检测。整体而言 这一建议的假设是，血浆/唾液中HPV16DNA检测作为 前瞻性试验中的高危HPVOPC将提供独立的预后数据，促进治疗 对高复发风险的患者进行分层，并提供检测复发的准备时间，这将 允许更早地发现和治疗。这将确定HPVOPC患者的高危队列 加强监测和治疗可改善预后。 我们预计，对HPV16DNA在HPVOPC患者血浆和唾液中的潜力进行严格的评估 患者将确定这种生物标记物在识别高复发风险患者方面的价值，并可以 迅速转化为临床使用。

Human Papilloma Virus (HPV) related oropharynx cancer (HPVOPC) is increasing in the US and now exceeds the incidence of cervical cancer. Patients with recurrent HPVOPC have an improved survival when compared to HPV negative OPC patients, and a majority of these patients have an opportunity for durable disease control. In general, these data imply that effective early detection of recurrent disease in HPVOPC patients offers an opportunity to effectively salvage patients with recurrent/metastatic disease. Recent studies have indicated that HPV16 DNA in plasma or salivary rinses may be used as a marker for disease in HPVOPC, and that there may adequate lead time between detection and recurrence to clinically intervene in patients with HPV16 DNA in saliva and/or plasma. Accordingly, we have developed a novel, genomic based saliva/plasma test for HPV16 DNA in a CLIA certified clinical laboratory. The overall hypothesis of this proposal is that validation of a HPV16 DNA assay in plasma/salivary rinse as a biomarker for high risk HPVOPC in a prospective trial will provide independent prognostic data, facilitate treatment stratification for patients at high risk of recurrence, and provide lead-time to detection of recurrence that will allow for earlier detection and treatment. This will identify a high-risk cohort of patients with HPVOPC for whom prognosis can be improved with intensified surveillance and treatment. We anticipate that rigorous evaluation of the potential of HPV16 DNA in plasma and saliva in HPVOPC patients will establish the value of this biomarker in identification of patients at high risk for recurrence and can be rapidly translated to clinical usage.