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The Importance of Tissue Banking and Tissue Research ...

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The Importance of Tissue Banking and Tissue Research ...

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    1. The Importance of Tissue Banking and Tissue Research: Presentation on May 5, 2004 at “Conflicts of Interest, Privacy/Confidentiality, and Tissue Repositories: Protections, Policies, and Practical Strategies”

    3. “Eye on the Prize” Improve the public’s health Conduct biomedical research to increase knowledge and understanding of biological processes. Respect subjects’ rights and personal autonomy; minimize harm.

    4. Use of Human Biological Materials in Research Human subject protections are applicable not only to clinical trials but also to the use of human biological materials in research studies, including basic science projects.

    5. Human Biological Materials HBMs Click and type your text hereClick and type your text here

    6. Repositories Tissue banks Stored blood/urine samples Freezers containing HBMs under individual control of principal investigators Histologic slide files Eiseman, E. and Haga, Susanne B., “Handbook of Human Tissue Sources,” Rand, 1999.

    7. Requirements of Repositories Security of samples IRB oversight Record keeping for informed consent Confidentiality Anonymize samples Increased workload !!

    8. Challenges Educating researchers Use of previously archived HBMs that were obtained without consent Re-use of HBMs Utility of anonymized samples Utility of autopsy specimens Assessment of risk by IRBs: What is genetic research? Is “genetic” research necessarily high risk? Demands on Tissue Repositories

    9. Educating Researchers Clinical research Translational research Basic science research What is a Repository?

    10. Anonymized Samples Value in basic science studies Disadvantages for translational/clinical research Studies not optimal Inability to perform long-term follow-up or prognostic studies Inability to request more of the same sample or different samples that don’t duplicate the original Clinically useful information cannot be conveyed (rare)

    11. Classifying HBMs: Assessment of Risk Click and type your text hereClick and type your text here

    12. Use of HBMs in “Genetic” Research: Assessment of Risk Germline Inheritability Implications for immediate and extended family Implications for ethnic group Use of “normal” tissues Somatic cell- less risk Acquired mutations Use of diseased tissues No implications for family

    13. Classifying HBMs: Assessment of Risk Click and type your text hereClick and type your text here

    14. HBMs in Research David Korn, “Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health,” in “National Bioethics Advisory Commission Report on Research Involving Human Biological Materials: Ethical Issues and Policy Guidance,” Volume II, January 2000.

    15. HBMs in Research: Early History Birth of the discipline of pathology: Autopsies performed by physicians on their deceased patients- Renaissance Italy Origin of the science of pathology: systemic study of the causes, mechanisms and natural history of diseases- 19th century Germany- Rudolph Virchow- the application of light microscopy to the study of diseased HBMs and the “cell theory of disease”

    16. HBMs in Research Historical use of archived specimens Re-use of specimens Pathologists and the histological slide file Increased demand for tissues Tissue microarrays Gene expression arrays

    17. Re-use of Archived Specimens DES: 1960s: Robert Scully at MGH Unusual tumor of the vagina- “clear cell adenocarcinoma of the vagina” Mothers had been treated with the nonsteroidal estrogenic hormone diethylstilbestrol during their pregnancies Establishment of a national registry Early detection and cure rate of 90%

    18. Re-use of Archived Specimens Hepatic Angiosarcoma 1940s-1950s: recognition of carcinogenic potential of occupational and environmental agents from suspicions of a pathologist observing small clusters of unusual neoplasms and thinking about shared histories Plastic starting materials: vinyl chloride and polyvinyl chloride Thorotrast (contrast agent)

    19. Re-use of Archived Specimens Bronchopulmonary Neoplasia Oscar Auerbach, East Orange, NJ Histopathological changes in the lungs of autopsied smokers compared to lung cancer New York Times obituary: “pathologist who found the first evidence in human lung tissue of a link between cancer and smoking”

    20. Archived Specimens Uranium Mining Geno Saccomanno Archive of pulmonary pathological and cytological specimens from underground uranium workers Bronchogenic carcinoma Apply direct, rapid modern detection technologies for candidate markers to existing specimens

    21. Autopsy Specimens: Brain Prion Diseases Cognitive Dementia Altzheimer’s disease

    22. Molecular Genetic Methods Lymphomas: Sklar and Cossman- 1970s Knowledge of normal genetic maturation of lymphocytes into immunocompetent cells Proliferative lymphoid lesions bearing different histopathologic diagnoses Fixed and frozen tissue collections

    23. Molecular Virology Viral Neoplasias Burkitt’s Lymphoma: childhood lymphoma prevalent in central Africa 1970s- Epstein and Barr show that Burkitt’s lymphoma cells harbor a virus Infectious mononucleosis Link between infectious mononucleosis and Hodgkin’s lymphoma

    24. Molecular Virology Human Papilloma Virus (HPV) Pap smears and collections of specimens Sequential patterns of progression from normal to dysplastic to neoplastic changes in cervical epithelial cells HPV difficult to culture New diagnostic molecular tests for “aggressive” subtypes

    25. Molecular Virology Influenza AFIP in 1990s Samples of autopsied lung tissue from 198 soldiers who died of the “Spanish Flu” in 1918 Understanding lethality Similarity to modern strains

    26. Molecular Virology HantaVirus 1993 cluster of deaths in the American Southwest Suspicious clinician, astute epidemiologist, observant Navajo elders, and specimen archives CDC libraries of viruses, viral proteins and serum specimens Pulmonary tissues from the autopsied victims

    27. Molecular Genetic Methods APC gene: adenomatous polyposis coli Frozen specimens of colorectal cancers Banked DNA specimens from patients with familial adenomatous polyposis Chromosome 5q

    28. Molecular Genetic Methods: Cancer Genome Anatomy Project 1997- CGAP launched by NCI Classify tumor genes by the type of cancer cell they come from and by degree of malignancy Comprehensive molecular characterization of cancer and precancerous cells

    29. Conclusion (Korn Report): “Now more than ever before, the dramatic growth of the biomedical knowledge base and the applicability of powerful new technologies to tiny samples of diseased human tissues offer promise of major breakthroughs in understanding – and effectively managing- some of the most intractable diseases of humankind. (cont’d)

    30. Conclusion (Korn Report): To achieve that promise, public policy must continue to encourage the accumulation of the human tissue archive and facilitate its accessibility for medical research.”

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