The Duke Biorepository was placed under central development and control in the year 2000 and continues to focus on the demands of contemporary investigators on tissue procurement. Over 10,000 patient consents, 5,000 banking events, and 40,000 biospecimens have been processed to date with storage of both formalin fixed paraffin embedded (FFPE) tissue and frozen tissue located within multiple freezers spanning temperatures in the range of -80 to -180 C depending on protocol requirements. Considerable effort confinues to be expended to assure compliance with IRB, NIH and HIPAA best pradices arid guidelines on banking human tissues. The biorepository in place today is the result of the combined efforts of the Duke Comprehensive Cancer Institute (DCCI) Breast SPORE, DCCI Shared Resource for Tissue and Blood Procurement, and the Duke University School of Medicine Research Foundafion (DUSOM-RF). The biorepository has been steadily collecting frozen and formalin-fixed paraffin embedded samples following standard operafing procedures established at the outset and meefing a high level of quality standards. The DCCI and the School of Medicine Research Foundation (SOMRF) have funded the collection of frozen and fixed fissues, both malignant and benign, under an 'excess fissue' protocol that utilizes freshly excised tissue that is available for research after the needs of the pathologic workup are met. This program procures fissues from many anatomic sites including breast. Recently Duke's Institute of Genome Science and Policy (IGSP), under the direction of Drs. Geoff Ginsburg and Tom Burke, inifiated a blood collection program that spans several departments and institutes. The Breast SPORE blood collection program served as the pilot for this much larger effort. The Breast SPORE tissue and blood collection effort utilizes much of the same infrastructure and personnel that are also supported by the DCCI, SOMRF, and IGSP. The Breast SPORE has served as the model for other recent tissue banking initiatives at Duke. The Duke biorepository has maintained a high level of operational and data management integrity utilizing standardized operating procedures and a robust informatics platform, entitled MAW3 . Existing infrastructure and resources continue to be ufilized to their maximum potenfial to minimize addifional costs. Expansion of blood collecfions and further collaborafions with Cancer Institute clinical trials activifies is planned.
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