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.
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