Cancer and Leukemia Group B Human Specimen Repositories

描述（由申请人提供）： 只有当患者的生物标本可以随时用于指导治疗需求、治疗选择和可用治疗的最佳剂量时，我们才能实现个性化癌症治疗的总体目标。此外，高质量标本库的可用性将极大地促进新的预后和预测因素的发现，所述标本库包含来自已经统一分期和治疗并且临床结果已知的患者的精心保存的材料，即，临床试验中的患者。开展相关的科学研究需要一个协调的系统，包括集中收集肿瘤细胞、组织和生物液体，在受控条件下储存，全面的库存，将标本分发给合格研究人员和从研究实验室接收分析结果的过程，以及解决负责任的研究行为的政策，包括保护患者机密。最终，实验室研究的结果必须与CALGB试验治疗患者的临床结局相关联，以便得出关于肿瘤生物学和治疗结局之间关系的统计学有效结论。因此，我们的具体目标如下：1. 2.维持中央图书馆标本库的核心运作，包括标本收集、储存、质量控制、分发、库存管理、保安及保密;在集团银行委员会的指导下，参与制定和实施人类标本库运营的最佳实践; 3.改善癌症合作小组和其他NCI资助的临床研究项目（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标本库的库存，并确保这些信息是公开的;和5。与合格的研究人员合作，利用CALGB标本库和相关临床数据进行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.