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iJournal of clinical oncology : official journal of the American Society of Clinical Oncology (27
October 2008)/ibr /br /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.br
/iBrian 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/i

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