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

人乳头状瘤病毒（HPV）相关的口咽癌（HPVOPC）在美国正在增加， 超过了宫颈癌的发病率。复发性HPVOPC患者的生存率有所改善， 与HPV阴性OPC患者相比，这些患者中的大多数有机会获得持久的治疗。 疾病控制。总的来说，这些数据意味着有效的早期发现HPVOPC中的复发性疾病 患者提供了有效挽救复发/转移性疾病患者的机会。 最近的研究表明，血浆或唾液中的HPV 16 DNA可作为HPV 16感染的标志物。 HPVOPC中的疾病，并且在检测和复发之间可能有足够的时间，以临床 干预唾液和/或血浆中HPV 16 DNA的患者。因此，我们开发了一种新的， 在CLIA认证的临床实验室中进行基于基因组的HPV 16 DNA唾液/血浆检测。整体 该建议假设是验证血浆/唾液冲洗液中的HPV 16 DNA测定作为 前瞻性试验中高危HPVOPC将提供独立的预后数据， 对高复发风险患者进行分层，并提供检测复发的提前期， 以便及早发现和治疗。这将确定一个高风险的HPVOPC患者队列， 加强监测和治疗可改善预后。 我们预计，对HPV 16 DNA在HPVVOPC患者血浆和唾液中的潜在性进行严格评估， 患者将确定该生物标志物在识别复发高风险患者中的价值， 迅速转化为临床应用。

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.