Cancer and Leukemia Group B Human Specimen Repositories

描述(申请人提供)：我们的癌症个体化治疗的总体目标只有在患者的生物样本随时可用来指导治疗需求、治疗选择和可用治疗的最佳剂量时才能实现。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，一个全面的库存管理系统，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)参与集团银行委员会开发一个网上门户网站，帮助描述所有合作集团标本储存库的库存情况，并确保这些信息可供公众查阅；4)与来自世界各地的合格研究人员合作，开展利用CALGB标本库和相关临床数据的优秀翻译研究项目。 相关性：我们的使命是明确的，通过研究改善癌症患者的结局。为了实现这一目标，我们追求一个贯穿于CALGB所有工作的中心主题，即癌症治疗的个体化。无论是通过使用分子标记来指导治疗，通过评估患者的DNA来确定处于毒性风险的个人，还是通过确定特殊人群的需求，我们相信，通过我们的工作，我们今天正在为患者提供明天的癌症治疗。

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 management system, 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 participate in the development of a web-based portal by the Group Banking Committee which will help to describe the inventory of all the Cooperative Group specimen repositories and insure that this information is publicly available; 4) To collaborate with qualified investigators from all over the world in the conduct of outstanding translational research projects that utilize the CALGB specimen repositories and associated clinical data. RELEVANCE: Our mission is clear, to improve the outcomes of cancer patients through research. To achieve this goal we pursue a central theme that pervades all of our work in CALGB, individualization of cancer treatment. Whether by use of molecular markers to direct therapy; assessment of a patient's DNA to identify individuals at risk for toxicity; or identification of the needs of special populations we believe that through our work we are offering patients tomorrow's Cancer Treatments Today.