Cancer and Leukemia Group B Human Specimen Repositories

癌症和白血病 B 组人类样本库

• 批准号: 7596998
• 负责人: RICHARD L SCHILSKY
• 金额: $ 114.59万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-06 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7596998
• 关键词: Address; Biological; Biological Assay; Cancer Center; Cancer and Leukemia Group B; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collection; Confidentiality; Confidentiality of Patient Information; Databases; Development; Doctor of Medicine; Dose; Enrollment; Equipment and supply inventories; Funding; Goals; Human; Laboratory Research; Laboratory Study; Link; Liquid substance; Malignant Neoplasms; Monitor; Operative Surgical Procedures; Outcome; Pathology; Patients; Policies; Predictive Factor; Process; Qualifying; Quality Control; Reproduction spores; Research Personnel; Research Project Grants; Science; Security; Specimen; Staging; System; Tissue Procurements; Tissues; Translational Research; Treatment outcome; Tumor Biology; cancer therapy; improved; meetings; neoplastic cell; prognostic; programs; quality assurance; repository; responsible research conduct; sample collection

DESCRIPTION (provided by applicant): Our overall goal of individualizing cancer treatment can only be met if biological specimens from patients are readily available to guide the need for therapy, the selection of therapy and the optimal dosing of available treatments. Furthermore, discovery of new prognostic and predictive factors will be greatly facilitated by the availability of high quality specimen repositories that contain carefully preserved materials derived from patients who have been uniformly staged and treated and for whom clinical outcomes are known, i.e., from patients enrolled on clinical trials. Conducting correlative science studies requires a coordinated system that includes centralized collection of tumor cells, tissues and biological fluids, storage under controlled conditions, a comprehensive inventory, a process to distribute specimens to qualified investigators and to receive the assay results from research laboratories, and policies to address responsible conduct of research, including safeguarding patient confidentiality. Ultimately, the results of the laboratory studies must be linked to and correlated with the clinical outcomes of patients treated on CALGB trials so that statistically valid conclusions can be drawn about the relationship between tumor biology and treatment outcomes. Thus, our specific objectives are as follows: 1. To sustain the core operations of the CALGB specimen repositories including specimen collection, storage, quality control, distribution, inventory management, security and confidentiality; 2. To participate in the development of and implement best practices for the operation of human specimen repositories under the guidance of the Group Banking Committee; 3. To improve the coordination of specimen collection, storage and distribution across the cancer cooperative groups and other NCI-funded clinical research programs such as cancer centers and SPOREs; 4. To describe the inventory of the CALGB specimen repositories and insure that this information is publicly available; and 5. To collaborate with qualified investigators in the conduct of outstanding translational research projects that utilize the CALGB specimen repositories and associated clinical data.

描述（由申请人提供）： 我们的个性化癌症治疗的总体目标只有在患者的生物标本很容易获得以指导治疗需求，选择治疗和最佳剂量的可用治疗剂量时才能满足。此外，通过可获得的高质量标本存储库的可用性，将发现新的预后和预测因素的发现，这些存储库的可用性将含有精心保存的材料，这些材料从已均匀上演和治疗的患者中得出，并为此而闻名，即从参加临床试验的患者中得知临床结果。进行相关科学研究需要一个协调的系统，其中包括集中的肿瘤细胞，组织和生物流体，在受控条件下的存储，全面的库存，将标本分配给合格研究者的过程，并接收研究实验室的测定结果，以及研究负责任的研究的策略，包括保护患者的负责任。最终，必须将实验室研究的结果与CALGB试验治疗的患者的临床结果联系起来并相关，以便可以就肿瘤生物学与治疗结果之间的关系得出统计上有效的结论。因此，我们的具体目标如下：1。维持CALGB标本存储库的核心操作，包括标本收集，存储，质量控制，分配，库存管理，安全性和机密性； 2。在集团银行委员会的指导下，参与人类标本存储库的运作的最佳实践和实施最佳实践； 3。为了改善癌症合作组和其他NCI资助的临床研究计划（例如癌症中心和孢子）的标本收集，存储和分布的协调； 4。描述CALGB标本存储库的清单，并确保该信息可公开可用；和5。与合格的研究人员合作，用于使用CALGB标本存储库和相关临床数据的杰出翻译研究项目。