Central Laboratory Core

中心实验室核心

• 批准号: 10470121
• 负责人: Joseph John Carter
• 金额: $ 3.93万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10470121
• 关键词: Anatomy; Anogenital cancer; Antibodies; Award; Binding; Biological; Biological Assay; Biological Specimen Banks; Biopsy; Blood specimen; Cells; Cervical; Clinical Data; Collection; Communication; Complex; Correlative Study; DNA Viruses; Drug or chemical Tissue Distribution; Ensure; Fred Hutchinson Cancer Research Center; Future; Genotype; Grant; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human Resources; Immune; Immune Tolerance; Immunohistochemistry; Immunooncology; Industry; Institution; Laboratories; Laboratory Research; Laboratory Scientists; Laboratory Study; Lead; Leadership; Malignant Neoplasms; Memory B-Lymphocyte; Mission; Names; Papillomavirus; Pathologist; Pathology; Peripheral Blood Mononuclear Cell; Phenotype; Play; Procedures; Protocols documentation; Quality Control; Recurrence; Research Personnel; Resource Sharing; Role; Running; Sampling; Sampling Studies; Serology test; Services; Shipping; Ships; Site; Specific qualifier value; Specimen; Stress; Techniques; Technology Transfer; Testing; Tissue Banks; Tissue Sample; Tissues; Training; Work; anti-tumor immune response; base; biomarker development; cancer prevention; clinically relevant; epidemiology study; experience; high risk; histological specimens; immunopathology; laboratory experience; predicting response; quality assurance; response; tumor; tumor microenvironment

PROJECT SUMMARY – CENTRAL LABORATORY CORE The Central Laboratory Core (CLC) will be based in Seattle within the laboratory of Dr. Denise Galloway (co-chair of Trial 1) and include the robust services of our Shared Resources Facilities at the Fred Hutchinson Cancer Research Center (Fred Hutch). While Dr. Galloway is best known for her work on the role high-risk human papillomaviruses (HPV) play in anogenital cancers, her lab is broadly focused on the role that small DNA viruses play in cancer. To aid in epidemiologic studies, the Galloway lab has developed serologic assays to detect and characterize papillomavirus-specific antibodies. These latter assays will be conducted in the CLC for trials 1 and 3 (see below). The CLC will oversee and efficiently manage and coordinate acquisition and shipping of protocol- specified biological specimens (with relevant clinical data) to appropriate laboratories for testing and to the central tumor/specimen repository for storage of specimens for future correlative laboratory studies. Dr. Joseph (Jody) Carter will lead the Core, and manage the CLC in Seattle, and will be available to advise the LAC partner institutions, if required, on management of sample storage, testing, and shipping of protocol-specific specimens and storage of samples for current trial endpoints and for future studies. The Core will work with each trial team to develop standard-operating protocols (SOPs) for each protocol. Dr. Carter has over 25 years of experience as a laboratory leader and will help each of the trials develop consistent approaches to quality control for each of the laboratory assays. Laboratory and pathology oversite provided in the Laboratory Core will be effectively matrixed with effort provided by Fred Hutch personnel named within the trials. For example, the extensive work on HPV- specific memory B cell responses conducted by Dr. Galloway's lab is included in Trial 1 but shares personnel and objectives with the CLC. Placement of the CLC at the Fred Hutch will also allow access to Fred Hutch Shared Resources, for example, the Immunopathology Lab directed by Dr. Robert Pierce. Dr. Pierce is a Board-certified Anatomic Pathologist with a strong academic and industry background in immuno-oncology. His laboratory research is focused on mechanisms of tumor-induced immune tolerance by which tumors can escape anti-tumor immune responses, including natural and therapy-induced responses. He is expert in using multiparametric immunohistochemistry (IHC) panels to quantitatively analyze the phenotype and tissue distribution of immune cells within the tumor microenvironment, and in the development of biomarkers to predict responses to immuno-oncology treatments. Although the details of Trials 2 and 3 (delayed onset trials) will be finalized only after the grant is awarded, we anticipate the Dr. Pierce will participate in training and quality assurance for pathology for trials 2 and 3, and for the correlative studies proposed for trial 3.

项目摘要——中央实验室核心 中央实验室核心 (CLC) 将设在西雅图 Denise 博士的实验室内 加洛韦（试验 1 的联合主席）并包括我们在 Fred 的共享资源设施的强大服务 哈钦森癌症研究中心（Fred Hutch）。加洛韦博士因扮演这个角色而闻名 高危人乳头瘤病毒 (HPV) 在肛门生殖器癌症中发挥作用，她的实验室广泛关注 小DNA病毒在癌症中发挥作用。为了帮助流行病学研究，加洛韦实验室开发了血清学 检测和表征乳头瘤病毒特异性抗体的测定。后面这些测定将在 试验 1 和 3 的 CLC（见下文）。 CLC 将监督并有效管理和协调协议的获取和运输 将指定的生物样本（带有相关临床数据）送至适当的实验室进行测试并送交 中央肿瘤/标本存储库，用于存储标本以供未来相关实验室研究。约瑟夫博士 (Jody) Carter 将领导核心团队并管理位于西雅图的 CLC，并将为 LAC 提供建议 合作机构（如果需要）负责特定协议的样本存储、测试和运输的管理 当前试验终点和未来研究的样本和样品存储。核心将与 每个试验团队为每个方案制定标准操作方案（SOP）。卡特博士拥有超过25年的经验 作为实验室领导者的经验，将帮助每个试验制定一致的质量方法 每个实验室测定的控制。 实验室核心提供的实验室和病理学现场将有效地与 由试验中指定的 Fred Hutch 人员提供的努力。例如，关于 HPV 的广泛工作 Galloway 博士实验室进行的特定记忆 B 细胞反应包含在试验 1 中，但共享人员 以及 CLC 的目标。将 CLC 放置在 Fred Hutch 也将允许访问 Fred Hutch 共享资源，例如罗伯特·皮尔斯博士领导的免疫病理学实验室。皮尔斯博士是一位 委员会认证的解剖病理学家，在免疫肿瘤学方面拥有强大的学术和行业背景。 他的实验室研究重点是肿瘤诱导的免疫耐受机制，肿瘤可以通过这种机制 逃避抗肿瘤免疫反应，包括自然反应和治疗诱导的反应。他擅长使用 多参数免疫组织化学 (IHC) 组合可定量分析表型和组织 免疫细胞在肿瘤微环境中的分布，以及生物标志物的开发 预测对免疫肿瘤治疗的反应。尽管试验2和试验3（延迟发作试验）的细节 只有在授予资助后才能最终确定，我们预计皮尔斯博士将参加培训和 试验 2 和 3 的病理学质量保证，以及试验 3 提出的相关研究的质量保证。