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: 7512220
• 负责人: RICHARD A LARSON
• 金额: $ 26.18万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7512220
• 关键词: Address; Autologous Stem Cell Transplantation; B-Lymphocytes; Back; Biopsy; Blood; Blood specimen; Bone Marrow; Cataloging; Catalogs; Cell Line; Cell division; Cell physiology; Cells; Chicago; Chromosome abnormality; Clinical; Clinical Data; Collaborations; Collection; Complication; Computer Terminals; Computers; Confidentiality of Patient Information; Consent Forms; Constitutional; Consultations; Core Facility; Cytogenetics; Cytotoxic Chemotherapy; Cytotoxic agent; DNA; Daily; Data; Data Analyses; Databases; Diagnosis; Educational workshop; Electronics; Elements; Enrollment; Ensure; Epithelial Cells; Equilibrium; Equipment and supply inventories; Family; Family Cancer History; Family history of; Family member; Fibroblasts; Freezing; Generations; Genetic; Genetic Predisposition to Disease; Grant; Hematopoietic; High Dose Chemotherapy; Hodgkin Disease; Human; Human Herpesvirus 4; Individual; Information Storage; Informed Consent; International; Interview; Invasive; Investigation; Karyotype; Laboratories; Life; Link; Maintenance; Malignant - descriptor; Malignant Neoplasms; Marrow; Medical Records; Meta-Analysis; Mission; Molecular Genetics; Monitor; Mutagens; Myeloid Leukemia; Names; Nature; Non-Hodgkin' s Lymphoma; Non-Malignant; Numbers; Nursing Research; Output; Paper; Pathway interactions; Patients; Population; Population Control; Prior Chemotherapy; Prior Therapy; Procedures; Process; Program Research Project Grants; Progress Reports; Publications; Published Comment; Quality Control; Questionnaires; Radiation therapy; Rate; Reagent; Recording of previous events; Records; Recovery; Registries; Relapse; Remission Induction; Research; Research Design; Research Ethics Committees; Research Personnel; Research Subjects; Resource Sharing; Resources; Retrieval; Risk; Role; Sampling; Schedule; Secure; Security; Site; Skin; Source; Specimen; Stress; Swab; Syndrome; System; Testing; Time; Toxin; Universities; Virus; Visual; Work; abstracting; alpha-Thalassemia; base; cancer cell; chemotherapy; computerized; cost; data acquisition; data management; day; design; genetic pedigree; genetic variant; human subject; interest; irradiation; leukemia; leukemogenesis; lymphoblastoid cell line; member; milliliter; peripheral blood; proband; programs; prospective; repaired; research study; response; sample collection; success; 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 种独特的临床病理学和细胞遗传学综合征。本作的特色之一 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 需要解决的问题来自个体患者对细胞毒治疗反应的性质。 也就是说，为什么有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、数据 管理、统计分析和组织培养核心 (A) 具有受试者招募的 4 重任务 知情同意、样本采集和存储、数据管理和统计协作，以及 EB病毒（EBV）转化的淋巴母细胞系的产生。这些功能很关键 成功完成 4 个项目中每一个项目的拟议调查，并有必要 支持并将来自各个实验室的结果联系在一起。这样，独特的患者 资源以最富有成效的方式共享。 Core A 与所有 4 个项目高度集成，这 在过去的资助期间，协作工作产生了 21 篇原创文章和摘要。 为了有序地获取患者材料并保存记录，我们建议继续我们的 核心 过去 22 年来管理这些功能的组件。核心 A 确保 为癌症细胞遗传学实验室前瞻性地获取适当的血液和骨髓样本 来自患有 t-MDS/t-AML、新发 AML 或原发性 MDS 的新患者。研究对象签署通知 由芝加哥大学机构审查委员会审查和批准的同意书 每年。采集后，临床标本将被登录并进行适当处理，然后 存储或交付给各个项目。每个项目 PI 对特定临床材料的请求 （正常或恶性的血液或骨髓细胞、口腔拭子中的 DNA、或来自特定患者的细胞系或 家庭成员）由核心 A 接收。来自项目调查员的请求具有最高优先级，但是 样本还与芝加哥大学和芝加哥大学的其他癌症研究人员共享 别处。核心 A 还负责产生永生化的类淋巴母细胞系 每个患有原发性或治疗相关性白血病的患者。因此，来自每个细胞的正常细胞和恶性细胞 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 来自活着的和已故的 t-AML 患者的种系 DNA。适当地为患者保密 受保护。数据表格受到保护。分配案件编号；出版物中不使用姓名。 研究数据不会存入患者的病历中。细胞清单和研究数据是 在密码安全下保存在机密电子文件中。数据库自动备份 每天；磁带是在场外制作和存放的，以提供进一步的保护。没有拨号访问权限 数据库和防病毒屏幕在网络上持续使用。访问限制为 4 核心 A 中的个人，每个人都完成了人类受试者保护方面的必修课程 由芝加哥大学机构审查委员会协调。