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，我们的个体化癌症治疗总体目标才能实现。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，全面的库存管理系统，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流程，以及解决负责任研究行为的政策，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）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，参与制定和实施人类标本库运营的最佳实践; 3）参与开发集团银行委员会的网络门户，该门户将有助于描述所有合作集团样本库的库存，并确保这些信息是公开的;四、与来自世界各地的合格研究人员合作，利用CALGB标本进行杰出的转化研究项目存储库和相关的临床数据。 相关性：我们的使命很明确，通过研究改善癌症患者的预后。为了实现这一目标，我们追求一个贯穿我们在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;评估患者的DNA以识别具有毒性风险的个体;还是识别特殊人群的需求，我们相信通过我们的工作，我们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.