Originally published as JCO Early Release 10.1200/JCO.2007.15.1712 on October 27 2008

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Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials

Brian R. Leyland-Jones, Christine B. Ambrosone, John Bartlett, Matthew J.C. Ellis, Rebecca A. Enos, Adekunle Raji, Michael R. Pins, Jo Anne Zujewski, Stephen M. Hewitt, John F. Forbes, Mark Abramovitz, Sofia Braga, Fatima Cardoso, Nadia Harbeck, Carsten Denkert, Scott D. Jewell

From the Emory University School of Medicine, Atlanta, GA; Roswell Park Cancer Institute; Southwest Oncology Group, Buffalo, NY; Endocrine Cancer Group, University of Edinburgh, Edinburgh Cancer Research Centre, Edinburgh, United Kingdom; Washington University in St Louis School of Medicine; Cancer and Leukemia Group B; American College of Surgeons Oncology Group, St Louis, MO; The EMMES Corporation; Cancer Therapy Evaluation Program, National Cancer Institute, Rockville; Tissue Array Research Program, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD; Eastern Cooperative Oncology Group Pathology Coordinating Office, Northwestern University, Evanston; Advocate Lutheran General Hospital Department of Pathology, Park Ridge, IL; Australian New Zealand Breast Cancer Trials Group; University of Newcastle, Newcastle, New South Wales, Australia; VM Institute of Research, Montreal, Quebec, Canada; Jules Bordet Institute, Brussels, Belgium; Technical University of Munich, Munich; Kommission für Translationale Forschung der Arbeitsgemeinschaft Gynakologische Onkologie, Taufkirchen; Charité University Hospital, Berlin; German Breast Group, Neu-Isenburg, Germany; Cancer and Leukemia Group B Pathology Coordinating Office; National Cancer Institute Cooperative Group Banking Committee, Ohio State University, Columbus, OH

Corresponding author: Brian Leyland-Jones, MD, PhD, Winship Cancer Institute, Emory University, 1365-C Clifton Rd, Atlanta, GA 30322; e-mail: leyland{at}emory.edu

Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue.

published online ahead of print at www.jco.org on October 27, 2008.

Supported by the Breast Cancer Research Foundation, the National Cancer Institute (NCI), the Breast International Group, and NCI-supported Cooperative Groups.

These guidelines are referenced on the World Wide Web at http://ctep.cancer.gov/guidelines/spec_bc_grptrials.html.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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