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

治疗相关白血病是细胞毒药物或放射治疗的晚期并发症。那里 至少有3种不同的临床病理和细胞遗传学综合征。它的一个特殊功能是 计划项目是4个单独的项目绝对依赖于患者材料，因为大多数 需要解决的问题中，有许多来自患者个体对细胞毒治疗的反应性质。 也就是说，为什么一些患者会发展为继发性白血病，而另一些患者则不会？患者访问权限、数据 管理、统计分析和组织文化核心(A)具有学科招聘的四重任务 和知情同意、标本获取和储存、数据管理和统计合作；以及 EB病毒(EBV)转化淋巴母细胞系的建立这些功能是至关重要的 为圆满完成4个项目中每一个项目的拟议调查，并有必要 支持并将来自不同实验室的结果联系起来。这样，独一无二的病人 以最有成效的方式共享资源。核心A与所有4个项目高度集成，这 在过去的赠款期间，合作工作产生了21篇原创文章和摘要。 为了提供有秩序地查阅患者资料和保存记录，我们建议继续我们的 核心管理这些职能的组成部分，过去22年来一直如此。核心A确保 预期将为癌症细胞遗传学实验室获得适当的血液和骨髓样本 来自t-MDS/t-AML、AML de nevo或原发MDS的新患者。研究对象签署知情协议 由芝加哥大学院校审查委员会审查和批准的同意书 每年一次。在收集之后，临床标本被登录，适当地处理，然后 存储或交付给各个项目。每个项目PI对特定临床材料的请求 (正常或恶性血液或骨髓细胞，口腔拭子DNA，或特定患者的细胞系，或 家庭成员)由Core A接收。来自程序调查员的请求具有最高优先级，但是 样本也与芝加哥大学和其他癌症研究人员分享 其他地方。核心A也有责任产生永生化的淋巴母细胞系 每个患有原发或与治疗相关的白血病的患者。因此，无论是正常细胞还是恶性细胞 患者被存储在核心设施中。这些资源使我们能够研究非恶性细胞和 T-AML活体和已故患者的生殖系dna。患者的保密是适当的 受到保护。数据表单是安全的。案例编号是指定的；出版物中不使用名称。 研究数据不会放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。数据库会自动备份 每天都会制作磁带，并在异地存储，以备进一步保护。不能拨入访问 数据库，并在网络上持续使用防病毒屏幕。访问限制为4个 核心A中的个人，每个人都完成了人体主体保护的必修课程 由芝加哥大学院校审查委员会协调。

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.