SPECIMEN ACCESSIONING

样本加入

基本信息

批准号：
8661013
负责人：
Allan D Hess
金额：
$ 9.14万
依托单位：
JOHNS HOPKINS UNIVERSITY
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/8661013
关键词：
Accounting Antineoplastic Agents Biological Assay Biopsy Biopsy Specimen Blood Bone Marrow Bone Marrow Cells Bone Marrow Neoplasms Cancer Center Cell Separation Cells Chemicals Clinical Clinical Research Clinical Treatment Clinical Trials Collection Comprehensive Cancer Center Cryopreservation Cytogenetics Data Databases Development Disease Marker Documentation Drug Kinetics Drug or chemical Tissue Distribution Effectiveness Ensure Environment Equipment Freezing Frozen Sections Goals Health Insurance Portability and Accountability Act Hematopoietic Neoplasms Hour Human Resources Individual Informed Consent Institutional Review Boards Intervention Laboratories Laboratory Research Link Location Maintenance Malignant Neoplasms Marrow Monitor Mononuclear Nature Nursing Research Operating Rooms Patients Peripheral Blood Mononuclear Cell Pharmaceutical Preparations Pharmacodynamics Pharmacology Plasma Population Privacy Procedures Process Protocols documentation Published Comment Qualifying Quality Control Research Research Infrastructure Research Personnel Resources Risk Sampling Secure Serum Services Shipping Ships Specimen Specimen Handling System Team Nursing Temperature Testing Therapeutic Time Tissue Banking Tissue Banks Tissue Sample Tissues Training Travel Tumor Markers Tumor-Associated Process Urine Whole Blood Work base cancer cell cell bank disease classification good laboratory practice in vivo lymph nodes magnetic beads neoplastic cell oncology peripheral blood programs quality assurance relational database sample collection tumor volunteer

项目摘要

The Specimen Accessioning Core (SAC) provides a centralized resource for the collection and processing of blood, bone marrow, and tumor cell samples from patients with malignancies as well as samples from normal volunteer donors. This Core was initially established in order to facilitate and support the ongoing laboratory and clinical research within the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC). In addition, the SAC provides rigorous quality assurance and quality control for the processing and storage of clinical samples. Thus, the specific aims of this Core are to: 1) Centralize accessioning of patient specimens, 2) Process patient specimens and tissue samples utilizing good laboratory practices (GLP) procedures, 3) Store specimens in a well-controlled and monitored environment in order to ensure sample integrity, 4) Fairly and equitably distribute accessioned samples to investigators with IRB-approved research questions. 5) Maintain a secure relational data base that includes detailed information on the handling and processing of the samples along with pertinent clinical and demographic data that correlate to the specimen. 6) Provide expertise and support to investigators in the planning of sample collection for the development of correlative biologic tests for clinical trials and for pharmacokinetic/pharmacodynamic analysis and, 7) Provide a mechanism to ensure that informed consent is provided and subjects are maximally protected when volunteering to donate tissues for ongoing and future research by maintaining an active IRB-approved clinical trial (currently RPN#00-01-27-09, Tissue and Cell Procurement Protocol) that identified the research nature of the bank and assures HIPAA-compliances. Lay: The Specimen Accessioning Core laboratory processes samples including blood, urine and bone marrow from patients treated with a variety of new anti cancer drugs in order to test the samples for the effectiveness of these new anti-cancer drugs and to determine how these drugs are metabolized by the patients. The Specimen Accessioning Core laboratory also processes and banks a variety of tumors from patients with hematologic (blood) cancers and makes the cancer cells available to investigators within the cancer center for study in the laboratory.

标本登录核心（SAC）为来自恶性肿瘤患者的血液，骨髓和肿瘤细胞样品的收集和处理提供了集中资源，以及正常志愿捐助者的样本。最初建立了该核心，以促进和支持约翰·霍普金斯（SKCCC）西德尼·金梅尔综合癌症中心的持续实验室和临床研究。此外，SAC为临床样品的处理和存储提供了严格的质量保证和质量控制。因此，该核心的具体目的是： 1）集中对患者标本的登录， 2）处理使用良好实验室实践（GLP）程序的患者标本和组织样本， 3）将标本存储在受控和受监控的环境中，以确保样本完整性， 4）与IRB批准的研究问题的研究人员公平且平等地分配了登录样本。 5）维护安全的关系数据库，其中包括有关样品处理和处理的详细信息，以及与样品相关的相关临床和人口统计数据。 6）为研究人员提供专业知识和支持样本收集的计划，以开发用于临床试验和药代动力学/药效分析的相关生物学测试以及，以及 7）提供一种机制，以确保提供知情同意并在自愿捐赠组织以进行持续和未来研究的情况下受到最大保护，并维持一项主动IRB批准的临床试验（目前RPN＃00-01-27-09，组织和细胞采购方案），组织和细胞采购方案），以确定银行的研究性质，并确定了银行的研究性质。 Lay：从接受各种新抗癌药物治疗的患者的核心实验室过程的样品，包括血液，尿液和骨髓，以测试样品是否有效，以确定这些药物如何由患者代谢。核心实验室的标本还可以处理来自血液学（血液）癌症患者的各种肿瘤，并使癌细胞可用于实验室癌症研究中心的研究者。