Patient Access, Data Management, Statistical Analysis, and Tissue Culture

患者访问、数据管理、统计分析和组织培养

• 批准号: 8319538
• 负责人: RICHARD A LARSON
• 金额: $ 29.03万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8319538
• 关键词: Address; Alkylating Agents; Back; Blood; Blood specimen; Cell Line; Cells; Chicago; Clinical; Collaborations; Collection; Complication; Confidentiality of Patient Information; Consent Forms; Constitutional; Consultations; Core Facility; Cytogenetics; Cytotoxic Chemotherapy; Cytotoxic agent; DNA; Data; Databases; Electronics; Enrollment; Equipment and supply inventories; Etiology; Family; Family member; Generations; Genetic Predisposition to Disease; Grant; Human; Human Herpesvirus 4; Individual; Informed Consent; Institutional Review Boards; Investigation; Laboratories; Life; Link; Maintenance; Malignant - descriptor; Malignant Neoplasms; Marrow; Medical Records; Mission; Myeloid Leukemia; Names; Nature; Non-Malignant; Normal Cell; Patients; Prior Chemotherapy; Process; Program Research Project Grants; Publications; Questionnaires; Radiation therapy; Recording of previous events; Records; Research; Research Personnel; Research Subjects; Resource Sharing; Resources; Role; Sampling; Secure; Security; Site; Source; Specimen; Swab; Syndrome; Time; Universities; Virus; Work; abstracting; alpha-Thalassemia; base; cancer cell; clinical material; data acquisition; data management; genetic pedigree; human subject protection; irradiation; leukemia; leukemogenesis; lymphoblastoid cell line; proband; programs; response; sample collection; tissue culture

Therapy-related leukemia is a late complication of treatment with cytotoxic drugs or irradiation. There are at least 3 distinctive clinicopathological and cytogenetic syndromes. One of the special features of this Program Project is that the 4 individual projects are absolutely dependent upon patient material, since most of the questions to be addressed arise from the nature of individual patient responses to cytotoxic therapy. That is, why do some patients develop secondary leukemia, and others not? The Patient Access, Data Management, Statistical Analysis, and Tissue Culture Core (A) has the 4-fold missions of subject recruitment and informed consent, specimen acquisition and storage, data management and statistical collaboration, and the generation of Epstein-Barr virus (EBV)-transformed lymphoblastoid cell lines. These functions are critical to the successful completion of the proposed investigations in each of the 4 projects and necessary to support and link together the results that come from the various laboratories. In this way, unique patient resources are shared in the most productive manner. Core A is highly integrated with all 4 projects, and this collaborative work has resulted in 21 original articles and abstracts during the past grant period. To provide an orderly access to patient material and to maintain records, we propose to continue our Core A component to manage these functions as it has for the past 22 years. Core A insures that appropriate blood and marrow specimens are obtained prospectively for the Cancer Cytogenetics Laboratory from new patients with t-MDS/t-AML, AML de novo, or primary MDS. Research subjects sign Informed Consent forms that are reviewed and approved by the University of Chicago Institutional Review Board annually. After collection, the clinical specimens are logged in, processed appropriately, and then either stored or delivered to the individual projects. Requests from each project PI for specific clinical materials (normal or malignant blood or marrow cells, DNA from buccal swabs, or cell lines from specific patients or family members) are received by Core A. Requests from program investigators have the highest priority, but samples have also been shared with other cancer researchers both at the University of Chicago and elsewhere. Core A also has the responsibility for generating an immortalized, lymphoblastoid cell line from each patient with a primary or therapy-related leukemia. Thus, both normal and malignant cells from each patient are stored in the Core facility. These resources allow us to study the non-malignant cells and germline DNA from both living and deceased patients with t-AML. Patient confidentiality is appropriately protected. Data forms are kept secured. Case numbers are assigned; names are not used in publications. Research data are not placed in patients' medical records. Inventories of cells and research data are maintained in confidential electronic files under password security. The database is automatically backed up on a daily basis; tapes are made and stored off site for further protection. There is no dial-in access to the database, and anti-virus screens are continuously employed on the network. Access is restricted to 4 individuals in Core A, each of whom has completed the required course in Human Subjects Protection coordinated by the University of Chicago Institutional Review Board.

治疗相关性白血病是细胞毒性药物或放射治疗的晚期并发症。那里 至少有3种不同的临床病理学和细胞遗传学综合征。这个的一个特点是 计划项目是4个单独的项目是绝对依赖于病人的材料，因为大多数 要解决的问题的性质产生的个别病人的反应细胞毒性治疗。 也就是说，为什么有些患者会发生继发性白血病，而另一些患者则不会？患者访问，数据 管理、统计分析和组织培养核心（A）具有受试者招募的四重任务 和知情同意，标本采集和储存，数据管理和统计协作，以及 EB病毒（EBV）转化的类淋巴母细胞系的产生。这些功能至关重要 成功完成4个项目中每个项目的拟议调查， 支持和链接来自不同实验室的结果。这样一来，独特的病人 以最有成效的方式分享资源。核心A与所有4个项目高度集成， 在过去的资助期内，合作产生了21篇原创文章和摘要。 为了让市民有秩序地取阅病人资料和保存纪录，我们建议继续推行 核心一个组成部分，以管理这些职能，因为它在过去22年。核心A确保 为癌症细胞遗传学实验室前瞻性地获得适当的血液和骨髓标本 来自新的t-MDS/t-AML、初治AML或原发性MDS患者。研究受试者签署知情 由芝加哥大学机构审查委员会审查和批准的知情同意书 每年。采集后，临床标本被记录，适当处理，然后 存储或交付给各个项目。每个项目PI对特定临床材料的要求 （正常或恶性血液或骨髓细胞，来自口腔拭子的DNA，或来自特定患者的细胞系，或 家庭成员）由核心A接收。来自项目调查人员的请求具有最高优先级，但 样本也与芝加哥大学的其他癌症研究人员共享， 其他地方核心蛋白A还负责从人源化细胞产生永生化的淋巴母细胞样细胞系。 每一位患者都患有原发性或治疗相关的白血病。因此，正常和恶性细胞从每个 患者被存放在核心设施中。这些资源使我们能够研究非恶性细胞， 来自存活和死亡的t-AML患者的生殖系DNA。病人的隐私是适当的 保护.数据格式是安全的。案例编号已分配;出版物中不使用名称。 研究数据不会被记录在患者的医疗记录中。细胞和研究数据的清单是 在密码保护下保存在机密电子文件中。数据库将自动备份 每天进行;制作磁带并储存在现场以外，以进一步保护。没有拨入访问 数据库和防病毒屏幕上不断采用的网络。访问仅限于4 核心A中的个人，每个人都完成了人类受试者保护的必修课程 由芝加哥大学机构审查委员会协调。