Cancer and Leukemia Group B Human Specimen Repositories

描述（由申请人提供）： 只有能够随时获得患者的生物样本来指导治疗需求、治疗选择和现有治疗的最佳剂量，我们个体化癌症治疗的总体目标才能实现。此外，高质量样本存储库的可用性将极大地促进新的预后和预测因素的发现，这些存储库包含精心保存的材料，这些材料来自经过统一分期和治疗且临床结果已知的患者，即来自参加临床试验的患者。进行相关科学研究需要一个协调的系统，其中包括肿瘤细胞、组织和生物液体的集中收集、受控条件下的储存、全面的库存、将样本分发给合格的研究人员并从研究实验室接收检测结果的流程，以及负责任地进行研究的政策，包括保护患者的机密性。最终，实验室研究的结果必须与 CALGB 试验中治疗的患者的临床结果相关联，以便能够得出关于肿瘤生物学和治疗结果之间关系的统计上有效的结论。因此，我们的具体目标如下： 1. 维持CALGB标本库的核心运营，包括标本采集、储存、质量控制、分发、库存管理、安全和保密； 2. 在集团银行委员会的指导下，参与人体标本库运营最佳实践的制定和实施； 3. 改善癌症合作小组和其他 NCI 资助的临床研究项目（例如癌症中心和 SPORE）之间标本采集、储存和分发的协调； 4. 描述 CALGB 样本库的库存并确保该信息是公开的； 5. 与合格的研究人员合作，利用 CALGB 标本存储库和相关临床数据开展杰出的转化研究项目。

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.