Skip to main content

Organizational Issues in Providing High-Quality Human Tissues and Clinical Information for the Support of Biomedical Research

  • Protocol
  • First Online:
Cancer Gene Profiling

Part of the book series: Methods in Molecular Biology ((MIMB,volume 576))

Summary

Superior-quality human tissues are required to support many types of biomedical research. To be useful optimally in supporting research, not only must these tissues be accurately diagnosed, but also the specific aliquots of tissue supplied to investigators must be accurately described as part of the quality control analysis of the tissue. Tissues should be collected, processed, and stored uniformly. Some tissues are provided to investigators from tissue banks for which tissues have been collected and processed according to standard operating procedures (SOPs) of the tissue bank. Other tissues provided to support research are collected and processed according to SOPs modified to meet investigator needs and requirements, i.e., prospective collection/processing. These different models of tissue collection require different goals, designs, and SOPs. The objectives of tissue repositories also vary based on the types of tissues provided (e.g., fresh tissue aliquots, fixed paraffin-embedded tissue, paraffin tissue sections, etc.) and how the tissues are to be used in research. For example, the potential use of tissues affects the need for extensive annotation of the specimen including both clinical information (e.g., clinical outcomes) and demographics. Specifically, if the tissues are to be used for extraction of proteins or basic studies of disease processes, less clinical information, if any, may be needed than if the tissues are to be used for the correlation of an aspect of the disease process with clinical outcome or response to a specific therapy. In this review, we describe, based on our experience, the major issues that should be addressed in designing and establishing a tissue repository.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Protocol
USD 49.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 159.00
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Abbreviations

CHTN:

Cooperative Human Tissue Network

DCIS:

Ductal carcinoma in situ

DMSO:

Dimethyl sulfoxide

GMP:

Good manufacturing practices

HIPAA:

Health Insurance Portability and Accountability Act

ISBER:

International Society for Biological and Environmental Repositories

ISO:

International Organization for Standardization

LCIS:

Lobular carcinoma in situ

LN2 :

Liquid nitrogen

NCI:

National Cancer Institute

OCT:

Optimal cutting temperature (compound for embedding specimens prior to cryosectioning)

PHI:

Protected health care information

PSA:

Prostatic-specific antigen

QA:

Quality assurance/management

QC:

Quality control

SOP:

Standard operating procedure

References

  1. Grizzle, W., Grody, W.W., Noll, W.W., Sobel, M.E., Stass, S.A., Trainer, T., Travers, H., Weedn, V. and Woodruff, K. (1999) Recommended policies for uses of human tissue in research, education, and quality control. Ad Hoc Committee on Stored Tissue, College of American Pathologists. Arch. Pathol. Lab. Med. 123, 296–300.

    CAS  PubMed  Google Scholar 

  2. Grizzle, W.E. (1989) Use of human tissues in research in matching needs, saving lives: building a comprehensive network for transplantation and biomedical research, The Annenberg Washington Program: Washington, DC.

    Google Scholar 

  3. Grizzle, W.E. and Sexton, K.C. (1999) Development of a facility to supply human tissues to aid in medical research. In Molecular Pathology of Early Cancer, Chapter 24 (S. Srivastava, D.E. Henson and A. Gazdar, eds.) IOS Press: Amsterdam, pp. 371–383.

    Google Scholar 

  4. Bailar, J.C., Gaylor, D., Grizzle, W.E., Grumbly, T., Kalman, D., Mahaffey, K., Matthews, H.B., Perera, F. and Waksberg, J. (1991) Monitoring human tissues for toxic substances, National Academy Press: Washington, DC.

    Google Scholar 

  5. Grizzle, W.E., Woodruff, K.H. and Trainer, T.D. (1996) The Pathologist’s role in the use of human tissues in research – legal, ethical and other issues. Arch. Pathol. Lab. Med. 120, 909–912.

    CAS  PubMed  Google Scholar 

  6. Grizzle, W.E., Aamodt, R., Clausen, K., LiVolsi, V., Pretlow, T.G. and Qualman, S. (1998) Providing human tissues for research: how to establish a program. Arch. Pathol. Lab. Med. 122, 1065–1076.

    CAS  PubMed  Google Scholar 

  7. Grizzle, W.E. and Fredenburgh, J. (2001) Avoiding biohazards in medical, veterinary and research laboratories. Biotech. Histochem. 76, 183–206.

    CAS  PubMed  Google Scholar 

  8. Jewell, S.D., Srinivasan, M., McCart, L.M., Williams, N., Grizzle, W.E., LiVolsi, V., MacLennan, G. and Sedmak, D.D. (2002) Analysis of the molecular quality of human tissues: an experience from the Cooperative Human Tissue Network. Am. J. Clin. Pathol. 118, 733–741.

    Article  CAS  PubMed  Google Scholar 

  9. Qualman, S.J., France, M., Grizzle, W.E., LiVolsi, V.A., Moskaluk, C.A., Ramirez, N.C. and Washington, M.K. (2004) Establishing a tumour bank: banking, informatics and ethics. Br. J. Cancer 90, 1115–1119.

    Article  CAS  PubMed  Google Scholar 

  10. Steg, A., Wang, W., Blanquicett, C., Grunda, J.M., Eltoum, I.A., Wang, K., Buchsbaum, D.J., Vickers, S.M., Russo, S., Diasio, R.B., Frost, A.R., LoBuglio, A.F., Grizzle, W.E. and Johnson, M.R. (2006) Multiple gene expression analyses in paraffin-embedded tissues by Taqman low density array: application to Hedgehog and Wnt pathway analysis in ovarian endometrioid adenocarcinoma. J. Mol. Diagn. 8, 76–83.

    Article  CAS  PubMed  Google Scholar 

  11. Steg, A., Vickers, S.M., Eloubeidi, M., Wang, W., Eltoum, I.A., Grizzle, W.E., Saif, M.W., Lobuglio, A.F., Frost, A.R. and Johnson, M.R. (2007) Hedgehog pathway expression in heterogeneous pancreatic adenocarcinoma: implications for the molecular analysis of clinically available biopsies. Diagn. Mol. Pathol. 16, 229–237.

    Article  CAS  PubMed  Google Scholar 

  12. Aamodt, R.L., Anouna, A., Baird, P., Beck, J.C., Bledsoe, M.A., DeSouza, Y., Grizzle, W.E., Gosh, J., Holland, N.T., Hakimian, R., Michels, C., Pitt, K.E., Sexton, K.C., Shea, K., Stark, A. and Vaught, J. (2005) Best practices for repositories I: collection, storage and retrieval of human biological materials for research. Cell Preserv. Technol. 3, 5–48.

    Article  Google Scholar 

  13. Grizzle, W.E., Semmes, O.J., Bigbee, W.L., Zhu, L., Malik, G., Oelschlager, D., Manne, B. and Manne, U. (2005) The need for the review and understanding of SELDI/MALDI mass spectroscopy data prior to analysis. Cancer Inform. 1, 86–97.

    CAS  Google Scholar 

  14. Grizzle, W.E., Bell, W.C. and Fredenburgh, J. (2005) Safety in biomedical and other laboratories. In Molecular Diagnostics, Chapter 33 (G. Patrinos and W. Ansorg, eds.) Elsevier Academic press: Burlington, MA, pp. 421–428.

    Google Scholar 

  15. Grizzle, W.E., Semmes, O.J., Bigbee, W.L., Malik, G., Miller, E., Manne, B., Oelschlager, D.K., Zhu, L. and Manne, U. (2005) Use of mass spectrographic methods to identify disease processes. In Molecular Diagnostics, Chapter 17 (G. Patrinos and W. Ansorg, eds.) Elsevier Academic press: Burlington, MA, pp. 211–222.

    Google Scholar 

  16. Grizzle, W.E., Bell, W. and Sexton, K.C. (2005) Best practices and challenges in collecting and processing human tissues to support biomedical research. AACR 96th Annual Meeting, Education Book, pp. 305–310.

    Google Scholar 

  17. Pitt, K., Campbell, L., Skubitz, A., Somiari, S., Sexton, K., Pugh, R., Aamodt, R., Baird, P., Betsou, F., Cohen, L., De Souza, Y., Gaffney, E., Geary, P., Grizzle, W.E., Gunter, E., Horsefall, D., Kessler, J., Michels, C., Kaercher, E., Morales, O., Morente, M., Morrin, H., Petersen, G., Robb, J., Seberg, O., Thomas, J., Thorne, H., Walters, C. and Riegman, P. (2005) Best practices for repositories: collection, storage, retrieval and distribution of biological materials for research, Second Edition. Cell Preserv. Technol. 3(1), 5–48.

    Article  Google Scholar 

  18. NCI (2007). National Cancer Institute Best Practices for Biospecimen Resources. http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf.

  19. Aamodt, R. and Grizzle, W.E. (2007) White paper: Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Working Group, pp. 1–95.

    Google Scholar 

  20. Huang, J., Qi, R., Quackenbush, J., Dauway, E., Lazaridis E. and Yeatman T. (2001) Effects of ischemia on gene expression. J. Surg. Res. 99, 222–7.

    Article  CAS  PubMed  Google Scholar 

  21. Dash, A., Maine, I.P., Varambally, S., Shen, R., Chinnaiyan, M. and Rubin, M.A. (2002) Changes in differential gene expression because of warm ischemia time of radical prostatectomy specimens. Am. J. Pathol. 161(5), 1743–1748.

    CAS  PubMed  Google Scholar 

  22. Spruessel, A., Steimann, G., Jung, M., Lee, S.A., Carr, T., Fentz, A.-J., Spangenberg, J., Zornig, C., Juhl, H.H. and David, K.A. (2004) Tissue ischemia time affects gene and protein expression patterns within minutes followingsurgical tumor excision. Biotechniques 36(6), 1030–1037.

    CAS  PubMed  Google Scholar 

  23. Baker, A.F., Dragovich, T., Ihle, N.T., William, R., Fernogilio-Preiser, C. and Powis, G. (2005) Stability of phosphoprotein as a biological marker of tumor signaling. Clin. Cancer Res. 11(12), 4338–4340.

    Article  CAS  PubMed  Google Scholar 

  24. Ayala, G., Thompson, T., Yang, G., Frolov, A., Li, R., Scardino, P., Ohori, M., Wheeler, T. and Harper, W. (2004) High levels of phosphorylated form of Akt-1 in prostate cancer and non-neoplastic prostate tissues are strong predictors of biochemical recurrence. Clin. Cancer Res. 10, 6572–6578.

    Article  CAS  PubMed  Google Scholar 

  25. Billings, P.E. and Grizzle, W.E. (2007) The gross room. In Theory and Practice of Histology Techniques, 6th Edition, (J. Bancroft and M. Gamble, eds.) Churchill Livingstone: Edinburgh, pp. 75–82.

    Google Scholar 

  26. McLerran, D., Grizzle, W.E., Feng, Z., Bigbee, W.L., Banez, L.L., Cazares, L.H., Chan, D.W., Diaz, J., Izbicka, E., Kagan, J., Malehorn, D.E., Malik, G., Oelschlager, D., Partin, A., Randolph, T., Rozenzweig, N., Srivastava, S., Srivastava, S., Thompson, I.M., Thornquist, M., Troyer, D., Yasui, Y., Zhang, Z., Zhu, L. and Semmes, O.J. (2008) Analytical validation of serum proteomic profiling for diagnosis of prostate cancer; sources of sample bias. Clin. Chem. 54(1), 44–52.

    Article  CAS  PubMed  Google Scholar 

  27. McLerran, D., Grizzle, W.E., Feng, Z., Thompson, I.M., Bigbee, W.J., Cazares, L.H., Chan, D.W., Dahlgren, J., Diaz, J., Kagan, J., Lin, D., Malik, G., Oelschlager, D., Partin, A., Randolph, T., Sokoll, L., Srivastava, S., Srivastava, S., Thornquist, M., Troyer, D., Wright, G.L., Zhang, Z., Zhu, L. and Semmes, O.J. (2008) SELDI-TOF MS whole serum proteomic profiling with IMAC surface does not reliably detect prostate cancer. Clin. Chem. 54(1), 53–60.

    Article  CAS  PubMed  Google Scholar 

  28. Edgerton, M.E., Morrison, C., LiVolsi, V.A., Moskaluk, C.A., Qualman, S.J., Washington, M.K. and Grizzle, W.E. (2008) A standards based ontological approach to information handling for use by organizations providing human tissue for research. Cancer Inform. 6, 127–137.

    PubMed  Google Scholar 

Download references

Acknowledgments

Our work is supported in part by the Cooperative Human Tissue Network (NCI #3U01CA044968), the Breast SPORE at UAB (NCI #1P50CA89019), the Pancreatic SPORE at UAB (NCI #P50CA101955), the Early Detection Research Network (NCI #5U24CA086359), and the Cardiovascular Medical Research Education Fund (TP1GR).

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2009 Humana Press, a part of Springer Science+Business Media, LLC

About this protocol

Cite this protocol

Bell, W.C., Sexton, K.C., Grizzle, W.E. (2009). Organizational Issues in Providing High-Quality Human Tissues and Clinical Information for the Support of Biomedical Research. In: Grützmann, R., Pilarsky, C. (eds) Cancer Gene Profiling. Methods in Molecular Biology, vol 576. Humana Press. https://doi.org/10.1007/978-1-59745-545-9_1

Download citation

  • DOI: https://doi.org/10.1007/978-1-59745-545-9_1

  • Published:

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-934115-76-3

  • Online ISBN: 978-1-59745-545-9

  • eBook Packages: Springer Protocols

Publish with us

Policies and ethics