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J Oncol Pract. 2018 Oct 04;JOP1800092. doi: 10.1200/JOP.18.00092. Epub 2018 Oct 04.

What Can Be Done to Improve Research Biopsy Quality in Oncology Clinical Trials?.

Journal of oncology practice

Katherine V Ferry-Galow, Vivekananda Datta, Hala R Makhlouf, John Wright, Bradford J Wood, Elliot Levy, Etta D Pisano, Alda L Tam, Susanna I Lee, Umar Mahmood, Lawrence V Rubinstein, James H Doroshow, Alice P Chen

Affiliations

  1. Frederick National Laboratory for Cancer Research, Frederick; National Cancer Institute, Bethesda MD; Beth Israel Deaconess Medical Center; Harvard Medical School; Massachusetts General Hospital, Boston, MA; American College of Radiology, Reston, VA; and University of Texas MD Anderson Cancer Center, Houston, TX.

PMID: 30285529 PMCID: PMC6237512 DOI: 10.1200/JOP.18.00092

Abstract

PURPOSE:: Research biopsy specimens collected in clinical trials often present requirements beyond those of tumor biopsy specimens collected for diagnostic purposes. Research biopsies underpin hypothesis-driven drug development, pharmacodynamic assessment of molecularly targeted anticancer agents, and, increasingly, genomic assessment for precision medicine; insufficient biopsy specimen quality or quantity therefore compromises the scientific value of a study and the resources devoted to it, as well as each patient's contribution to and potential benefit from a clinical trial.

METHODS:: To improve research biopsy specimen quality, we consulted with other translational oncology teams and reviewed current best practices.

RESULTS:: Among the recommendations were improving communication between oncologists and interventional radiologists, providing feedback on specimen sufficiency, increasing academic recognition and financial support for the time investment required by radiologists to collect and preserve research biopsy specimens, and improving real-time assessment of tissue quality.

CONCLUSION:: Implementing these recommendations at the National Cancer Institute's Developmental Therapeutics Clinic has demonstrably improved the quality of biopsy specimens collected; more widespread dissemination of these recommendations beyond large clinical cancer centers is possible and will be of value to the community in improving clinical research and, ultimately, patient care.

References

  1. Anal Biochem. 2014 Aug 15;459:1-11 - PubMed
  2. J Clin Oncol. 2013 Jan 1;31(1):17-22 - PubMed
  3. Radiology. 2001 Jun;219(3):785-92 - PubMed
  4. J Thorac Oncol. 2013 Apr;8(4):436-42 - PubMed
  5. JAMA. 2015 Jan 27;313(4):390-7 - PubMed
  6. Mod Pathol. 2013 Nov;26(11):1413-24 - PubMed
  7. J Vasc Interv Radiol. 2010 Jul;21(7):969-75 - PubMed
  8. Clin Cancer Res. 2016 Feb 15;22(4):1000-10 - PubMed
  9. J Clin Pathol. 2004 Sep;57(9):897-902 - PubMed
  10. J Natl Cancer Inst. 2015 Feb 06;107(4):null - PubMed
  11. Am J Surg Pathol. 2013 Mar;37(3):443-6 - PubMed
  12. Nat Rev Clin Oncol. 2013 Aug;10(8):437-50 - PubMed
  13. Annu Rev Pharmacol Toxicol. 2016;56:211-28 - PubMed
  14. Nat Rev Cancer. 2017 Apr;17(4):223-238 - PubMed
  15. Clin Cancer Res. 2001 Oct;7(10):2971-6 - PubMed
  16. Eur J Cancer. 2009 Jan;45(2):228-47 - PubMed
  17. Semin Oncol. 2016 Aug;43(4):484-91 - PubMed
  18. PLoS One. 2012;7(12):e50494 - PubMed
  19. Nat Biotechnol. 2013 Nov;31(11):1023-31 - PubMed
  20. J Clin Oncol. 2015 Dec 1;33(34):4023-31 - PubMed
  21. Clin Cancer Res. 2010 Nov 15;16(22):5447-57 - PubMed
  22. Clin Cancer Res. 2016 Jan 15;22(2):357-65 - PubMed
  23. Semin Oncol. 2016 Aug;43(4):427-35 - PubMed
  24. Clin Cancer Res. 2016 Jul 15;22(14):3683-94 - PubMed
  25. Anal Biochem. 2008 Oct 15;381(2):240-7 - PubMed
  26. J Vasc Interv Radiol. 2016 Jan;27(1):8-19 - PubMed
  27. Radiology. 2015 Mar;274(3):917-26 - PubMed
  28. J Mol Diagn. 2016 Jan;18(1):51-67 - PubMed

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