Southwest EDRN Clinical Validation Center for Head and Neck Cancer

西南头颈癌EDRN临床验证中心

• 批准号: 10706931
• 负责人: Karen Sue Anderson
• 金额: $ 74.77万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706931
• 关键词: Academic Medical Centers; Address; Age; Antibodies; Area; Arizona; Back; Binding; Biological Assay; Biological Markers; Blinded; Blood; COVID-19; COVID-19 assay; Cancer Control; Cancer Etiology; Cancer Patient; Caring; Cervical Cancer Screening; Clinical; Clinical Management; Clinical Research; Collaborations; Collection; Controlled Clinical Trials; DNA; Data; Detection; Development; Diagnosis; Diagnostic; Dryness; Early Detection Research Network; Early Diagnosis; Enrollment; Enzyme-Linked Immunosorbent Assay; Feasibility Studies; Fingers; Foundations; Funding; Gender; General Population; Geographic Locations; Goals; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; High Risk Woman; Home; Human; Human Papillomavirus; Human papillomavirus 16; Immune; Immunoglobulin G; Incidence; Individual; Infection; Infrastructure; Laboratories; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methodology; Methods; Morbidity - disease rate; Newly Diagnosed; Nucleic Acid Amplification Tests; Nucleic Acids; Oncoproteins; Oral health; Oropharyngeal; Participant; Patients; Peer Review Grants; Performance; Phase; Phase III Clinical Trials; Plasma; Population; Predictive Value; Prevalence; Prospective Studies; Publications; Reagent; Recurrent Malignant Neoplasm; Research; Research Design; Research Institute; Resources; Risk; Risk Assessment; Saliva; Salivary; Sampling; School Dentistry; Screening for cancer; Serology; Serology test; Serum; Specimen; Speed; Spottings; System; Technology; Testing; Texas; Universities; Vaccination; Vaccines; Validation; Viral; advanced disease; aggressive therapy; anticancer research; assay development; biobank; biomarker development; biomarker performance; biomarker validation; blood-based biomarker; cancer biomarkers; cancer prevention; cancer recurrence; carcinogenesis; circulating biomarkers; clinical application; cohort; comparative; coronavirus disease; design; digital; experience; feasibility testing; human migration; immunogenicity; improved; innovation; instrument; malignant oropharynx neoplasm; men; migration; mortality; novel; operation; patient population; peripheral blood; programs; prospective; public health priorities; repository; research clinical testing; response; risk prediction; saliva diagnostic; saliva sample; salivary assay; sample collection; screening; screening program; serological marker; success; underserved community; validation studies

Project Summary/Abstract The goal of the EDRN Southwest Clinical Validation Center for Head and Neck Cancer is to improve oropharyngeal cancer screening through the rigorous validation of salivary biomarkers. The scientific approach of our Center is based on several fundamental principles. First, that human papillomaviral (HPV) infection and persistence induces carcinogenesis in the oropharynx over decades, generating well-documented circulating and salivary viral nucleic acid and serologic biomarkers. These biomarkers have not yet been tested in rigorous, prospective studies with centralized CLIA/CAP biomarker validation. Second, the low incidence requires that effective screening paradigms for oropharyngeal cancers (OPC) use novel systems for large-scale prospective studies using self-collection sampling, digital enrollment, and distributive systems to enable enrollment in underserved communities. Third, that the clinical management of positive biomarkers be rigorously addressed. Our proposal builds on our extensive experiences with cancer biomarker development, verification, validation, innovative clinical study management, and expertise in HPV oropharyngeal cancer screening. Our previous results on HPV serologic biomarkers have been confirmed in blinded phase 2 multicenter validation studies. Our results have shown that multiplexed panels of IgG antibodies for HPV16 are required for adequate predictive value. Our Meso Scale Diagnostics, LLC. (MSD®) team has fielded over 3,000 instruments worldwide, and over 700 commercially available biomarker assay kits. Their expertise at serologic assay development led to one of their V-PLEX® serology panels being selected by Operation Warp Speed as the basis of its standard binding assays for immunogenicity assessments in all funded Phase III clinical trials of COVID vaccines. We will use the MSD MULTI-ARRAY® platform to migrate the HPV serologic markers for target clinical applications in saliva. This represents an ongoing collaboration with experts in large-scale self-collection salivary biomarker screening at Arizona State University, experts on head and neck cancer screening at Baylor University Medical Center, and AT Still University (ATSU) School of Dentistry and Oral Health. We will generate high-quality well-characterized samples to validate circulating and salivary biomarkers to enhance oropharyngeal cancer screening. Adhering to the principles of PRoBE design, we will perform Phase 2 validation of HPV serology and nucleic acid testing with cancer patient and control sera and saliva, followed by developing and testing the methodology needed to conduct a prospective Phase 4 salivary screening study. We will provide a resource for expertise and clinical repository for the rigorous validation of salivary and circulating biomarkers for cancer screening.

项目摘要/摘要 EDRN西南头颈癌临床验证中心的目标是改善口咽癌 通过唾液生物标志物的严格验证进行筛选。我们中心的科学方法是基于几个 基本原则。首先，人类乳头瘤病毒(HPV)感染和持续感染会在 口咽部几十年来，产生了有充分证据的循环和唾液病毒核酸和血清生物标志物。 这些生物标记物尚未在CLIA/CAP集中生物标记物验证的严格前瞻性研究中进行测试。 其次，低发病率要求口咽癌(OPC)的有效筛查模式使用新的系统 对于使用自我收集采样、数字登记和分布式系统的大规模前瞻性研究，以实现 在服务不足的社区招生。第三，严格处理阳性生物标记物的临床管理。 我们的建议建立在我们在癌症生物标记物开发、验证、验证、创新 HPV口咽癌筛查方面的临床研究管理和专业知识。我们以前对HPV血清学的研究结果 生物标志物已在2期盲法多中心验证研究中得到确认。我们的结果表明，多路传输 要有足够的预测价值，需要一组针对HPV16的抗体。我们的中尺度诊断有限责任公司。(MSD®) 该团队在全球部署了3000多台仪器和700多套商用生物标记物分析试剂盒。他们的 在血清学分析开发方面的专业知识使他们的V-PLEX®血清学小组之一被Warp行动选中 在所有资助的第三阶段临床试验中，速度作为其免疫原性评估的标准结合分析的基础 冠状病毒疫苗。我们将使用MSD MULTI-ARRAY®平台将HPV血清标志物移植到目标临床 在唾液中的应用这代表了与大规模自收集唾液生物标记物专家的持续合作 亚利桑那州立大学的筛查，贝勒大学医学中心的头颈癌筛查专家，以及 在静物大学(Atsu)牙科和口腔健康学院。我们将生成高质量的、具有良好特性的样本，以 验证循环和唾液生物标志物以增强口咽癌筛查。坚持以下原则 探针设计，我们将对癌症患者和对照进行HPV血清学和核酸测试的第二阶段验证 血清和唾液，然后开发和测试进行预期阶段4唾液所需的方法学 筛查研究。我们将提供专业知识资源和临床资料库，以严格验证唾液和 用于癌症筛查的循环生物标记物。