Elliot B Levy1, Maria I Fiel2, Stanley R Hamilton3, David E Kleiner4, Shannon J McCall5, Peter Schirmacher6, William Travis7, Michael D Kuo8, Robert D Suh9, Alda L Tam10, Shaheen U Islam11, Katherine Ferry-Galow12, Rebecca A Enos13, James H Doroshow14, Hala R Makhlouf14. 1. Center for Interventional Oncology, Radiology and Imaging Sciences and Center for Cancer Research, National Institutes of Health, Bethesda, MD. 2. Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY. 3. Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. 4. Laboratory of Pathology, National Institutes of Health, Bethesda, MD. 5. Department of Pathology, Duke University, Durham, NC. 6. Institute of Pathology, University of Heidelberg, Heidelberg, Germany. 7. Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY. 8. Department of Radiology Medical Artificial Intelligence Laboratory Initiative, The University of Hong Kong, Hong Kong. 9. Department of Radiological Sciences, Ronald Reagan UCLA Medical Center, Los Angeles, CA. 10. Department of Interventional Radiology, MD Anderson Cancer Center, Houston, TX. 11. Division of Pulmonary, Critical Care & Sleep Medicine, Medical College of Georgia, Augusta University, Augusta, GA. 12. Laboratory of Human Toxicology and Pharmacology, Applied/ Developmental Research Support Directorate, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD. 13. The EMMES Corporation, Rockville, MD. 14. Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
Abstract
PURPOSE: National Cancer Institute (NCI)-sponsored clinical trial network studies frequently require biopsy specimens for pharmacodynamic and molecular biomarker analyses, including paired pre- and post-treatment samples. The purpose of this meeting of NCI-sponsored investigators was to identify local institutional standard procedures found to ensure quantitative and qualitative specimen adequacy. METHODS: NCI convened a conference on best biopsy practices, focusing on the clinical research community. Topics discussed were (1) criteria for specimen adequacy in the personalized medicine era, (2) team-based approaches to ensure specimen adequacy and quality control, and (3) risk considerations relevant to academic and community practitioners and their patients. RESULTS AND RECOMMENDATIONS: Key recommendations from the convened consensus panel included (1) establishment of infrastructure for multidisciplinary biopsy teams with a formalized information capture process, (2) maintenance of standard operating procedures with regular team review, (3) optimization of tissue collection and yield methodology, (4) incorporation of needle aspiration and other newer techniques, and (5) commitment of stakeholders to use of guideline documents to increase awareness of best biopsy practices, with the goal of universally improving tumor biopsy practices.
PURPOSE: National Cancer Institute (NCI)-sponsored clinical trial network studies frequently require biopsy specimens for pharmacodynamic and molecular biomarker analyses, including paired pre- and post-treatment samples. The purpose of this meeting of NCI-sponsored investigators was to identify local institutional standard procedures found to ensure quantitative and qualitative specimen adequacy. METHODS: NCI convened a conference on best biopsy practices, focusing on the clinical research community. Topics discussed were (1) criteria for specimen adequacy in the personalized medicine era, (2) team-based approaches to ensure specimen adequacy and quality control, and (3) risk considerations relevant to academic and community practitioners and their patients. RESULTS AND RECOMMENDATIONS: Key recommendations from the convened consensus panel included (1) establishment of infrastructure for multidisciplinary biopsy teams with a formalized information capture process, (2) maintenance of standard operating procedures with regular team review, (3) optimization of tissue collection and yield methodology, (4) incorporation of needle aspiration and other newer techniques, and (5) commitment of stakeholders to use of guideline documents to increase awareness of best biopsy practices, with the goal of universally improving tumor biopsy practices.
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