Cancer and Leukemia Group B Human Specimen Repositories

描述(由申请人提供)： 只有当患者的生物样本随时可以指导治疗需要、治疗选择和可用治疗的最佳剂量时，我们才能实现癌症个体化治疗的总体目标。此外，高质量的标本储存库的提供将极大地促进新的预后和预测因素的发现，这些标本储存库包含精心保存的材料，这些材料来自已进行统一分期和治疗的患者，以及已知临床结果的患者，即来自登记参加临床试验的患者。开展相关科学研究需要一个协调的系统，其中包括集中收集肿瘤细胞、组织和生物液，在受控条件下储存，全面清点，一个向合格研究人员分发标本和从研究实验室接收化验结果的程序，以及处理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接受CALGB试验的患者的临床结果相关联，以便能够就肿瘤生物学和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标本储存库的核心业务，包括标本收集、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，参与制定和实施人类标本储存库运作的最佳做法；3.改善癌症合作小组和其他NCI资助的临床研究项目(如癌症中心和孢子)之间标本收集、储存和分发的协调；4.描述CALGB标本储存库的库存，并确保这些信息是公开的；5.与合格的研究人员合作，开展利用CALGB标本库和相关临床数据的优秀翻译研究项目。

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.