Southwest EDRN Clinical Validation Center for Head and Neck Cancer

西南头颈癌EDRN临床验证中心

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/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严格验证唾液生物标志物进行筛选我们中心的科学方法基于多种方法。首先，人乳头瘤病毒（HPV）感染和持续存在会诱发癌症。几十年来，口咽部产生了有据可查的循环和唾液病毒核酸和血清学生物标志物。这些生物标志物尚未通过集中 CLIA/CAP 生物标志物验证的严格前瞻性研究进行测试。其次，低发病率要求口咽癌 (OPC) 的有效筛查范例使用新型系统使用自我收集抽样、数字登记和分配系统进行大规模前瞻性研究，以实现第三，严格解决阳性生物标志物的临床管理问题。我们的提案建立在我们在癌症生物标志物开发、验证、验证、创新方面的丰富经验的基础上临床研究管理以及 HPV 口咽癌筛查的专业知识。我们之前的 HPV 血清学结果。生物标志物已在盲法 2 期多中心验证研究中得到证实，我们的结果表明，多重研究。我们的 Meso Scale Diagnostics, LLC (MSD®) 需要 HPV16 的 IgG 抗体组。团队已在全球部署了 3,000 多种仪器和 700 多种商用生物标志物检测试剂盒。血清学检测开发方面的专业知识使得他们的 V-PLEX® 血清学面板之一被 Warp 行动选中在所有资助的 III 期临床试验中，速度作为其免疫原性评估的标准结合测定的基础我们将使用 MSD MULTI-ARRAY® 平台迁移 HPV 血清学标记物以用于目标临床。这代表了与大规模自采集唾液生物标志物方面专家的持续合作。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 AT 斯蒂尔大学 (ATSU) 牙科和口腔健康学院我们将生成高质量的特征良好的样本。验证循环和唾液生物标志物以加强口咽癌筛查。 PRoBE 设计，我们将对癌症患者和对照进行 HPV 血清学和核酸检测的 2 期验证血清和唾液，然后开发和测试进行前瞻性第四阶段唾液所需的方法我们将为唾液和唾液的严格验证提供专业知识资源和临床资源库。用于癌症筛查的循环生物标志物。