Cancer and Leukemia Group B Human Specimen Repositories

描述（由申请人提供）：我们个体化癌症治疗的总体目标只有在患者的生物标本可以很容易地指导治疗的需要、治疗的选择和可用治疗的最佳剂量时才能实现。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，这些标本库包含精心保存的材料，这些材料来自已统一分期和治疗的患者，并且临床结果已知，即来自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，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，一个全面的库存管理系统，将标本分发给合格的研究人员并从研究实验室接收分析结果的过程，以及负责任的研究行为政策，包括保护患者的隐私。最终，实验室研究的结果必须与CALGB试验治疗患者的临床结果联系起来并相互关联，这样才能得出肿瘤生物学与治疗结果之间关系的统计有效结论。因此，我们的具体目标如下：1)维持CALGB标本库的核心业务，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，参与制定和实施人体标本库的最佳操作规范；3)参与集团银行委员会网络门户网站的开发，该门户网站将有助于描述所有合作集团标本库的库存，并确保这些信息是公开的；4)与来自世界各地的合格研究人员合作，利用CALGB标本库和相关临床数据进行优秀的转化研究项目。

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 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.