Tissue Core

组织核心

• 批准号: 7802156
• 负责人: LAURA Z RASSENTI
• 金额: $ 75.05万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7802156
• 关键词: Affect; American; B-Lymphocytes; Biochemical; Biochemistry; Biological Assay; Biology; CD19 gene; Cells; Chronic Lymphocytic Leukemia; Classification; Cleaved cell; Clinical; Clinical Trials; Cytogenetics; Data; Databases; Development; Diagnosis; Disease; Disease Progression; Drug Formulations; Enrollment; European; Family member; Fluorescent in Situ Hybridization; Genetic; Genotype; Health Insurance Portability and Accountability Act; IGH@ gene cluster; Immunologics; Immunophenotyping; Interphase; Lymphoid; Lymphoma; Molecular; Neoplastic B-Lymphocyte; Outcome; Patients; Phenotype; Procedures; Process; Regulation; Research; Research Personnel; Residual Neoplasm; Sampling; Site; Specimen; Standardization; Surface Antigens; Testing; Tissues; United States; Validation; Work; ZAP-70 Gene; alemtuzumab; base; cell transformation; clinical research site; follow-up; gene discovery; innovation; leukemia; neoplastic cell; novel; repository; rituximab; trafficking; tumor

We have established a Consortium Tissue Core to process, store, and distribute samples from patients with Chronic Lymphocytic Leukemia. One of the aims of this proposal is to continue to serve as a repository for all CLL samples from patients diagnosed and collected at the participating CRC clinical sites. The processing, storage, and distribution of each sample will be performed according to established standard operating procedures in accordance with HIPAA regulations. The Tissue Core will also perform a basic set of assays on all viably stored CLL samples from each patient upon initial receipt. These tests will include: immunophenotyping to determine the surface antigen phenotype, ZAP-70 expression, and determination of the expressed immunoglobulin heavy chain gene (IgVH) mutational status. Testing for Minimal Residual Disease (MRD), soluble CD20/CD52 (rituximab/alemtuzumab), and B CLL turnover rates will be performed on specific CLL samples enrolled in clinical trials during follow-up and pre & post therapy as needed. In addition, the serial samples of specific CLL patients will be characterized according to their surface antigen phenotype by multiparameter flow cytometric analysis. This will allow the CRC investigators to examine for longitudinal changes in the leukemia cell's genotype, biochemistry, and/or immunologic phenotype and correlate these data to clinical outcome. The Tissue Core will seek to standardize interphase Fluorescence in situ Hybridization (FISH) studies by distributing specific characterized CLL samples to the participating CRC cytogenetics sites at which FISH analysis will be conducted. This validation will provide innovative and accurate interphase FISH studies for CRC clinical trials and research investigators. The Tissue Core will also collect, process, and validate specimens from affected family members with CLL for targeted genetic studies performed by CRC investigators. Finally, the Tissue Core will distribute specific characterized samples as requested by CRC investigators for hypothesis driven studies. This trafficking of characterized CLL samples, with their associated clinical and demographic data, will enable and facilitate the development of new CLL therapies.

我们已经建立了一个财团组织核心，以处理，存储和分发来自 慢性淋巴细胞性白血病。该提议的目的之一是继续作为存储库 来自参与CRC临床部位诊断和收集的患者的所有CLL样品。这 每个样品的处理，存储和分布将根据既定标准进行 根据HIPAA法规的操作程序。组织芯还将执行基本集合 初次收到时，对所有患者的所有患者的CLL样品的测定。这些测试将包括： 免疫表型确定表面抗原表型，ZAP-70表达和测定 表达的免疫球蛋白重链基因（IGVH）突变状态。测试最小残留物 疾病（MRD），可溶性CD20/CD52（利妥昔单抗/Alemtuzumab）和B CLL周转率将进行 根据需要在随访期间和治疗后接受临床试验的特定CLL样品。在 此外，将根据其表面抗原的特定CLL患者的串行样品进行表征 通过多参数流式细胞仪分析表型。这将使CRC调查人员可以检查 白血病细胞基因型，生物化学和/或免疫学表型的纵向变化 将这些数据与临床结果相关联。组织芯将寻求标准化相间荧光 原位杂交（FISH）研究通过向参与的特定表征的CLL样品分发 将进行鱼类分析的CRC细胞遗传学位点。该验证将提供创新的和 用于CRC临床试验和研究研究人员的准确相间鱼类研究。组织芯将 还收集，处理和验证来自患有CLL的家庭成员的标本，以实现遗传 CRC研究人员进行的研究。最后，组织芯将分布特定的特定表征 根据CRC研究者的要求，用于假设驱动的研究。这种贩运的特征 CLL样品及其相关的临床和人口统计数据将使并促进发展 新的CLL疗法。