Central Laboratory Core

中心实验室核心

• 批准号: 10689741
• 负责人: Joseph John Carter
• 金额: $ 12.18万
• 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/10689741
• 关键词: Anatomy; Anogenital cancer; Antibodies; Award; Binding; Biological; Biological Assay; Biological Specimen Banks; Biopsy; Blood specimen; Board Certification; 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; Histology; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human Resources; Immune; Immune Tolerance; Immunohistochemistry; Immunooncology; Industry; Institution; Laboratories; Laboratory Research; Laboratory Scientists; Laboratory Study; 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; Site; Specific qualifier value; Specimen; Stress; Techniques; Technology Transfer; Testing; Tissue Banks; Tissue Sample; Tissues; Training; Work; anti-tumor immune response; biomarker development; cancer prevention; clinically relevant; epidemiology study; experience; high risk; 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.

项目总结-中心实验室核心 中心实验室核心（CLC）将设在西雅图的Denise博士实验室内 加洛韦（试验1的联合主席），并包括我们在弗雷德共享资源设施的强大服务 哈钦森癌症研究中心（弗雷德·哈奇）。虽然加洛韦博士最出名的是她在这个角色上的工作 高危人乳头瘤病毒（HPV）在肛门生殖器癌中的作用，她的实验室广泛关注的作用， 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 用于检测和表征乳头瘤病毒特异性抗体的测定。后一项试验将在 试验1和3的CLC（见下文）。 CLC将监督、有效管理和协调协议的获取和运输- 指定的生物样本（连同相关临床数据）送往适当的实验室进行检测， 中央肿瘤/标本库，用于储存标本，以备将来进行相关实验室研究。约瑟夫博士 卡特将领导核心，管理西雅图的CLC，并将为LAC提供建议 合作机构（如需要），负责管理样本储存、检测和方案特定样本的运输 用于当前试验终点和未来研究的样本和样本储存。核心将与 每个试验团队为每个方案制定标准操作方案（SOP）。卡特医生在美国 作为实验室领导者的经验，并将帮助每个试验制定一致的质量方法 每个实验室测定的对照。 实验室核心中提供的实验室和现场病理学将与以下内容有效地结合起来 试验中提到的Fred Hutch人员提供的努力。例如，关于HPV的广泛工作- 由加洛韦博士实验室进行的特定记忆B细胞反应包括在试验1中，但人员共享 和目标。在弗雷德哈奇放置CLC也将允许访问弗雷德哈奇 共享资源，例如，由罗伯特·皮尔斯博士指导的免疫病理学实验室。皮尔斯博士是个 委员会认证的解剖病理学家，具有强大的免疫肿瘤学学术和行业背景。 他的实验室研究主要集中在肿瘤诱导免疫耐受的机制上， 逃避抗肿瘤免疫应答，包括自然和治疗诱导的应答。他擅长使用 多参数免疫组织化学（IHC）面板，以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3（延迟发作试验）的细节 将最终确定后，赠款被授予，我们预计皮尔斯博士将参加培训， 试验2和3的病理学质量保证，以及试验3拟定的相关研究的质量保证。