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.

人乳头瘤病毒 (HPV) 相关口咽癌 (HPVOPC) 在美国呈上升趋势，目前 超过宫颈癌的发病率。复发性 HPVOPC 患者的生存率在以下情况下得到改善： 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早期检测 HPVOPC 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，血浆或唾液冲洗液中的 HPV16 DNA 可用作 HPVOPC 中的疾病，并且在检测到临床复发之间可能有足够的时间 对唾液和/或血浆中含有 HPV16 DNA 的患者进行干预。因此，我们开发了一本小说， 在 CLIA 认证的临床实验室中进行基于基因组的唾液/血浆 HPV16 DNA 检测。整体 该提案的假设是，验证血浆/唾液冲洗液中的 HPV16 DNA 检测作为生物标志物 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 对复发高风险患者进行分层，并提供检测复发的准备时间，从而 以便及早发现和治疗。这将确定 HPVOPC 患者的高风险队列，以进行治疗 通过加强监测和治疗可以改善其预后。 我们预计对血浆和唾液中 HPV16 DNA 在 HPVOPC 中的潜力进行严格评估 患者将确定该生物标志物在识别复发高风险患者方面的价值，并且可以 迅速转化为临床应用。