Optimizing an assay for high risk HPV DNA in body fluids

优化体液中高危 HPV DNA 的测定

• 批准号: 9933588
• 负责人: Joseph A Califano
• 金额: $ 33.87万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-12 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9933588
• 关键词: Aftercare; Biological Assay; Body Fluids; CLIA certified; Cervix carcinoma; Clinical; Clinical Trials; DNA; Data; Detection; Development; Generations; Genomics; HPV-High Risk; Head and neck structure; Human Papillomavirus; Human papillomavirus 16; Incidence; Laboratories; Laboratory Research; Patients; Phase; Plasma; Publishing; Recurrence; Residual Neoplasm; Saliva; Salivary; Subgroup; Testing; Validation; base; cohort; design; genome sequencing; high risk; malignant oropharynx neoplasm; whole genome

Project Abstract High risk human papilloma virus related oropharynx carcinoma (HPVOPC) incidence is rapidly increasing, and has surpassed the incidence of cervical carcinoma in the US. Published data show the independent association of post treatment HPV DNA detection in plasma and salivary rinses with HPVOPC recurrence, and concepts in development for NCI supported head and neck clinical trials in HPVOPC currently include research laboratory based assays for detection of HPV DNA in body fluids, including plasma and saliva. This project includes a 1) a UH2 phase for rational development of an HPV DNA based body fluid test based on whole genome sequencing data, followed by analytic validation of this test in plasma and salivary rinses within a CLIA-certified laboratory setting; and, 2) a UH3 clinical validation phase of this test within a CLIA-certified laboratory setting for a cohort of HPVOPC patients. At the conclusion of this project, a rationally designed, optimized test for the presence of HPV DNA in HPV OPC patients w ill be available for clinical trials within a CLIA-certified laboratory setting.

项目摘要 高危人乳头瘤病毒相关口咽癌(HPVOPC)的发病率正在迅速上升， 并且已经超过了美国的宫颈癌发病率。公布的数据显示，独立的 治疗后唾液和血浆中HPVDNA检测与HPVOPC复发的关系 目前正在开发的NCI支持的HPVOPC头颈部临床试验的概念包括 以研究实验室为基础的检测体液中HPV DNA的方法，包括血浆和唾液。 该项目包括1)合理开发基于HPV DNA的体液检测的UH2阶段 基于全基因组测序数据，然后在血浆和唾液中分析验证这一测试 在CLIA认证的实验室环境中漂洗；以及，2)此测试的UH3临床验证阶段 CLIA认证的实验室环境，适用于一组HPVOPC患者。在这个项目结束时，一个 合理设计、优化的HPV OPC患者HPV DNA检测方法将适用于 在CLIA认证的实验室环境中进行临床试验。