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Tissue Biorepositories: Do You Really Want to Know How the Sausage is Made?

Tissue Biorepositories: Do You Really Want to Know How the Sausage is Made?. David A. August Professor of Surgery The Cancer Institute of New Jersey UMDNJ / Robert Wood Johnson Medical School. The Cancer Institute of New Jersey. CINJ “SNP” Protocol.

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Tissue Biorepositories: Do You Really Want to Know How the Sausage is Made?

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  1. Tissue Biorepositories: Do You Really Want to Know How the Sausage is Made? • David A. August • Professor of Surgery • The Cancer Institute of New Jersey • UMDNJ / Robert Wood Johnson Medical School The Cancer Institute of New Jersey

  2. CINJ “SNP” Protocol • Goal:to identify genetic variants as markers for • risk of developing breast cancer • earlier age of diagnosis • outcomes • 1168 patients consented • 980 genomic DNAs isolated • Demographics to date from chart review • Collaborative studies with: • Dr. Arnold J. Levine • Dr. Vassiliki Karantza-Wadsworth • Dr. Shridar Ganesan • Dr. Bruce Haffty • Dr. Mark Brenneman

  3. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

  4. NCI_Best_Practices_060507biospecimens.cancer.gov

  5. Clinical Basic Types of Tissue Support • Tissue banking (de- identified:discarded, annotated) • Protocol specific support • Translational research • Bench support

  6. Front End / Back End • Clinical Processes (collectors) • Protocol development • Regulatory approval • Subject consent • Tissue acquisition • Clinical analyses • Initial processing • Clinical annotation • Linkage/de-identification • Tissue storage • Acquisition QA • Longitudinal annotation • Technical Processes (repository, recipients) • Tissue storage • Quality assurance • Sample preparation • Sample distribution • Database management • End user support

  7. Clinical Uses • Prognosis • Risk assessment • Pharmacodynamics (Phase O trials) • “Fingerprinting” • Inheritance analysis • Etiology • Response assessment • Response prediction

  8. The Worker Bees • Director • Pathologist • Database development/management/support • Manager • Technicians (histo, retrieval, IHC, TMA) • Data managers, research nurses, chart abstracters • Regulatory manager • Protocol support (writer, “shepherd”, consultant) • Consent docents

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