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

HPV 相关口咽癌疾病状态的血浆和唾液生物标志物

• 批准号: 10461775
• 负责人: Joseph A Califano
• 金额: $ 39.15万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-08 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10461775
• 关键词: Adopted; Aftercare; Age; Biological Assay; Biological Markers; Blood; CLIA certified; Cancer Patient; Cause of Death; Cessation of life; Clinical; Clinical Trials; Collection; DNA; Data; Detection; Disease; Disease Marker; Early Diagnosis; Early treatment; Endocrine; Evaluation; Genome; Genomics; Goals; HPV oropharyngeal cancer; HPV-High Risk; Human Papilloma Virus Vaccination; Human Papillomavirus; Human papillomavirus 16; Incidence; Intervention; Laboratories; Lead; Malignant neoplasm of cervix uteri; Measurement; Measures; Metastatic/Recurrent; Monitor; Neurosecretory Systems; Ovarian; Patients; Performance; Plasma; Prognosis; Prostate; Recurrence; Recurrent disease; Risk; Saliva; Salivary; Site; Stratification; Testing; Thyroid Gland; Time; Translating; Tumor Markers; United States; Validation; base; burden of illness; cancer recurrence; clinically relevant; cohort; cost; disorder control; high risk; improved; malignant oropharynx neoplasm; men; multi-site trial; novel; patient stratification; performance tests; predictive test; prevent; prognostic; prognostic assays; prospective; salivary assay; standard of care; treatment stratification; viral DNA

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.

与人乳头状瘤病毒（HPV）相关的口咽癌（HPVOPC）在美国，现在正在增加 超过宫颈癌的发生率。当复发性HPVOPC患者的生存率提高时 与HPV阴性OPC患者相比，大多数这些患者都有机会耐用 疾病控制。通常，这些数据表明在HPVOPC中有效地发现了复发性疾病 患者提供了有效挽救复发/转移性疾病的患者的机会。 最近的研究表明，血浆或唾液冲洗中的HPV16 DNA可以用作标记 HPVOPC中的疾病，并且在检测与复发之间可能有足够的交货时间到临床 干预唾液和/或血浆中HPV16 DNA的患者。因此，我们开发了一部小说， 在CLIA认证的临床实验室中，基于基因组的唾液/血浆测试。总体 该提议的假设是在等离子体/唾液冲洗中对HPV16 DNA分析的验证作为生物标志物 前瞻性试验中的高风险HPVOPC将提供独立的预后数据，促进治疗 重复发生高风险的患者的分层，并为检测复发提供了详细时间的分层 允许早期检测和治疗。这将确定HPVOPC患者的高风险队列 通过加强监视和治疗可以改善预后。 我们预计对HPV16 DNA在HPVOPC中的HPV16 DNA潜力的严格评估 患者将确定该生物标志物在鉴定出高风险复发风险的患者中的价值，并且可以 迅速转化为临床用法。