Pathology Core

病理学核心

• 批准号: 10470364
• 负责人: Scott D Jewell
• 金额: $ 21.51万
• 依托单位: CORIELL INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-16 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10470364
• 关键词: AML/MDS; Aftercare; Animal Model; Biological Assay; Biological Markers; Biological Process; Biological Specimen database; Biopsy; Blood; Bone Marrow; Bone Tissue; Cell Count; Cell Line; Cells; Clinical; Clinical Data; Clinical Trials; Clinical trial protocol document; Collaborations; Collection; Communities; DNA; DNA Methylation; Data; Databases; EZH2 gene; Endogenous Retroviruses; Epigenetic Process; Evaluation; Flow Cytometry; Gene Expression; Generations; Genomics; Goals; Hematopoietic Neoplasms; Histology; Image; Immune; Immunohistochemistry; Immunologic Markers; Immunologic Monitoring; Immunophenotyping; Indiana; Institutes; Institution; Label; Laboratories; Location; Malignant Neoplasms; Maryland; Measures; Methylation; Monitor; Nucleic Acids; Participant; Pathologic; Pathology; Patients; Phenotype; Principal Investigator; Procedures; Process; RNA; Randomized; Refractory; Relapse; Research; Research Personnel; Research Project Grants; Research Support; Resources; Sampling; Science; Serum; Services; Ships; Site; Specimen; T-Lymphocyte; Technology; Testing; Time; Tissue Microarray; Tissues; Universities; base; bead chip; biobank; brca gene; cohort; digital imaging; epigenetic therapy; exhaustion; image archival system; insight; novel therapeutic intervention; performance site; peripheral blood; prospective; repository; therapeutic evaluation; transcriptome; treatment response; tumor

Abstract Pathology/Biospecimen/Biorepository Core (PBC) The PBC will manage the collection of patient-derived biospecimens from blood, bone marrow and tissue (cancer and normal) as determined by the trial parameters often with collections occurring at pre and post treatment time points to meet the research aims of the proposed SPORE projects. The PBC Core will provide collection materials, specimen labels and manage shipments of biospecimens to VAI. The specimen derivatives will be distributed to the locations for assay performance site including the SPORE’s Genomics Core and other collaborating project investigators. Pathology-based histology assessment, DNA methylation EPIC BeadChip arrays and immunophenotype monitoring will be provided by the PBC Core. The PBC Core will assess and maintain excellent quality in the collection of biospecimens for use in the correlative science research that are used to determine efficacy, biological function and mechanistic details for the evaluation of the therapeutic treatments and scientific goals of the SPORE projects. For Project 1, the Core will collect process and store peripheral blood and bone marrow samples related to a randomized study of MC180295+Atezolizumab, MC180295+DAC and MC180295+DAC+Atezolizumab in relapsed or refractory AML/MDS. Biospecimens collected will be managed by the PBC Core with nucleic acids being sent to the Genomics Core for assessment of epigenetic parameters. Immune cell parameters (cell numbers, gene expression in T-cells, T-cell exhaustion parameters) will be measured in the PBC Flow Cytometry Core. Approximately 600 data points will be assayed from this cohort. For Project 2, the Core will collect samples from the clinical trial of combined DNMT and EZH1/2 inhibition that is planned to begin in year 2 with collection and management of peripheral blood and tumor biopsies pre and post therapy to assess epigenetic modulation and biomarkers (done in the Genomics Core) and Immune biomarkers (done in the PBC Core). Approximately 1,400 data points are expected from this cohort. Project 3 will use the PBC Core resources to collect and manage pre and post therapy biospecimens and to provide specimen DNA and RNA derivatives to the Genomic Core for BRCAness gene expression, DNA methylation and global gene expression including ERVs. The PBC Core’s access to the VAI Flow Cytometry Core will provide immune monitoring and the PBC Core’s access to the VAI Genomics Core will provide the Methylation EPIC BeadChip array for evaluation. Approximately 640 to 800 specimens will be tested to meet the aims of this project. The Pathology and Biospecimen Core will provide access and distribution of project specimens to downstream assay sites, whether they are within the Core Technologies at VAI, the Genomics Core at Coriell, principal investigators laboratories or other approve investigators beyond the principal SPORE investigators.

摘要病理学/生物标本/生物库核心（PBC） PBC将管理来自血液、骨髓和组织（癌症）的患者生物标本的采集 和正常），如试验参数所确定的，通常在治疗前和治疗后时间进行采集 点，以满足拟议的SPORE项目的研究目标。PBC核心将提供收集 材料、样本标签和管理生物样本到奥钢联的运输。样本衍生物将是 分发到检测性能站点的位置，包括SPORE的基因组学核心和其他 合作项目调查员。基于病理学的组织学评估，DNA甲基化EPIC BeadChip 阵列和免疫表型监测将由PBC核心提供。建设和平委员会核心委员会将评估和 在生物标本的采集中保持优良的质量，用于相关的科学研究， 用于确定疗效、生物学功能和机制细节，以评估治疗 SPORE项目的治疗和科学目标。对于项目1，核心将收集过程并存储 与MC180295 + Atezolizumab随机研究相关的外周血和骨髓样本， MC180295 + DAC和MC180295 + DAC + Atezolizumab治疗复发性或难治性AML/MDS。生物样本 收集的样本将由PBC核心管理，核酸将被送往基因组学核心进行评估 表观遗传参数。免疫细胞参数（细胞数量、T细胞中的基因表达、T细胞耗竭 参数）将在PBC流式细胞术核心中测量。将分析约600个数据点 从这个队列。对于项目2，中心将从联合使用DNMT和EZH1/2的临床试验中采集样本 计划在第2年开始进行外周血和肿瘤采集和管理的抑制 治疗前后活检，以评估表观遗传调节和生物标志物（在Genomics Core中完成） 和免疫生物标志物（在PBC核心中完成）。预计该队列约有1，400个数据点。 项目3将利用PBC核心资源收集和管理治疗前后的生物标本， 为BRCAness基因表达的基因组核心提供样本DNA和RNA衍生物，DNA 甲基化和包括ERV的整体基因表达。PBC Core访问VAI流式细胞仪 核心将提供免疫监测，PBC核心访问VAI Genomics核心将提供 用于评价的甲基化EPIC BeadChip阵列。将对大约640至800个样本进行试验，以满足 这个项目的目标。病理学和生物标本核心将提供项目的访问和分发 样本到下游检测中心，无论它们是在奥钢联的核心技术，基因组学 Coriell的核心、主要研究者实验室或主要SPORE以外的其他批准研究者 investigators.