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

基本信息

批准号：
8120886
负责人：
RICHARD A LARSON
金额：
$ 29.65万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
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/8120886
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 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 Informed Consent International Interview 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&apos s Lymphoma Non-Malignant Nursing Research Output Paper Pathway interactions Patients Population Control Prior Chemotherapy Prior Therapy Procedures Process Program Research Project Grants Progress Reports Publications Published Comment Quality Control Questionnaires Radiation therapy 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 clinical material computerized cost data acquisition data format data management design genetic pedigree genetic variant high risk human subject protection interest irradiation leukemia leukemogenesis lymphoblastoid cell line meetings member milliliter patient population peripheral blood proband programs prospective repaired research study response sample collection success tissue culture working group

项目摘要

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.

与治疗相关的白血病是用细胞毒性药物或辐照治疗的晚期并发症。那里至少有3种独特的临床病理和细胞遗传学综合征。其中的特殊功能之一计划项目是四个单个项目绝对取决于患者材料，因为大多数项目要解决的问题是由个体患者对细胞毒性疗法的反应的性质引起的。也就是说，为什么有些患者会患上次要白血病，而另一些患者没有？患者访问，数据管理，统计分析和组织培养核心（a）具有4倍对象招聘的任务以及知情同意，标本获取和存储，数据管理和统计协作以及爱泼斯坦 - 巴尔病毒（EBV）转化的淋巴细胞细胞系的产生。这些功能至关重要成功完成了这4个项目中每个项目的拟议调查，这是必要的支持并将来自各个实验室的结果链接在一起。这样，独特的病人资源以最有效的方式共享。核心A与所有4个项目都高度融合，这在过去的赠款期间，协作工作导致了21篇原始文章和摘要。为了提供有序的患者材料访问并维护记录，我们建议继续我们的核心一个组件来管理这些功能，就像过去22年一样。核心一个确保为癌症遗传学实验室提供了适当的血液和骨髓标本来自T-MDS/T-AML，AML DE NOVO或初级MD的新患者。研究对象的标志通知芝加哥大学机构审查委员会审查和批准的同意书每年。收集后，登录临床标本，适当处理，然后进行处理存储或交付给各个项目。每个项目的请求PI对特定临床材料（正常或恶性血液或骨髓细胞，来自颊拭子的DNA或特定患者的细胞系或核心A收到家庭成员）。样本还与芝加哥大学和别处。核心A还负责从中产生永生的淋巴母细胞细胞系每个患有主要或治疗相关白血病的患者。因此，来自每个的正常细胞和恶性细胞患者存储在核心设施中。这些资源使我们能够研究非恶性细胞，并 T-AML的生物和已故患者的种系DNA。患者机密性适当受保护。保留数据表格。案例编号已分配；名称不在出版物中。研究数据未放置在患者的病历中。细胞和研究数据的库存是在密码安全性下维护在机密的电子文件中。数据库自动备份每天；制作磁带并将其存储在现场以进行进一步保护。无法访问数据库和防病毒屏幕在网络上不断使用。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要课程由芝加哥大学机构审查委员会协调。