The purpose of the Clinical Data and Data Management Core (CDDM) is to support the clinical data requirements of current and future SPORE projects. Three distinct requirements activities are encompassed within this core: (1) data management for clinical trials conducted through the SPORE; (2) collection of clinical data on patients with breast cancer receiving their care within SPORE institutions; and (3) maintenance of the database storing information; and (3) maintenance of the database storing information on specimens processed by the Tissue and Pathology Core. Many of the SPORE projects will require the services provided by the CDDM Core. For projects involving a clinical trial, data managers of the CDDM will perform all tasks related to completion of study forms for trial participants. The Clinical Research Information system (CRIS) a multi- institutional relational clinical database will support SPORE activities in threeways. First survey data from patients will help identify families for possible inclusion in the High-Risk Patients and Families core, or subjects eligible for specific studies. Second, CRIS data linked to specimens will allow for correlations between specific laboratory finding sand clinical outcomes. Third, CRIS will serve as the database for selected observational studies. The Specimen Tracking Information Program (STIP) will support the handling of patient specimens for a number of SPORE projects, and is instrumental in constructing the multi-institutional virtual SPORE specimen bank. The activities of the CDDM Core will facilitate current and future translational research studies. Working together, the HRPF, TP, and CDDM Cores will generate a very large bank of specimens linked to comprehensive coded clinical data on risk factors, stage at diagnosis, response to therapy, complications, and survival. Studies using this resource to examine the relationship between established and experimental laboratory assays and risk factors/outcomes have the potential to make important contributions to our understanding of the etiology, prevention, and treatment of breast cancer.
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