1. Cancer and Leukemia Group B Pathology Committee guidelines for tissue microarray construction representing multicenter prospective clinical trial tissues.
- Author
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Rimm DL, Nielsen TO, Jewell SD, Rohrer DC, Broadwater G, Waldman F, Mitchell KA, Singh B, Tsongalis GJ, Frankel WL, Magliocco AM, Lara JF, Hsi ED, Bleiweiss IJ, Badve SS, Chen B, Ravdin PM, Schilsky RL, Thor A, and Berry DA
- Subjects
- Clinical Trials as Topic, Humans, Multicenter Studies as Topic, Specimen Handling methods, Biomarkers, Tumor analysis, Tissue Array Analysis methods
- Abstract
Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population.
- Published
- 2011
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