Harmonization of molecular monitoring of chronic myeloid leukemia therapy in Japan

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dc.contributor.authorYoshida, C.
dc.contributor.authorFletcher, L.
dc.contributor.authorOhashi, K.
dc.contributor.authorWakita, H.
dc.contributor.authorKumagai, T.
dc.contributor.authorShiseki, M.
dc.contributor.authorMatsuei, K.
dc.contributor.authorInokuchi, K.
dc.contributor.authorHatta, Y.
dc.contributor.authorShirasugi, Y.
dc.contributor.authorYamaguchi, T.
dc.contributor.authorSakamoto, J.
dc.contributor.authorBranford, S.
dc.contributor.authorSakamaki, H.
dc.date.issued2012
dc.description.abstractBACKGROUND: Real-time quantitative polymerase chain reaction (RQ-PCR) has been widely used for molecular monitoring for patients with chronic myeloid leukemia (CML). Currently, RQ-PCR is not based on the concept of international scale (IS) in Japan; mainly because none of the domestic laboratories have obtained their own conversion factor (CF) which makes it possible to convert locally scaled BCR-ABL (BCR-ABL (L)) value to the IS (BCR-ABL (IS)). To join the global trend of molecular assessment of BCR-ABL in CML patients, we have tried to obtain a CF in Japan. METHODS: Samples from 55 patients were exchanged between the Japanese laboratory and the reference laboratory in Adelaide, and BCR-ABL and internal control gene transcripts of the samples were measured using RQ-PCR. The patient bias conversion method was used to determine the CF for the IS using the Bland and Altman method. RESULTS: The local CF in the Japanese laboratory was determined to be 0.87. Based on this CF, 0.1% BCR-ABL (IS), defined as major molecular response, becomes equivalent to 731 copy/μg RNA BCR-ABL (L). CONCLUSION: This study is the first to introduce a laboratory-specific CF for harmonizing RQ-PCR methodology for detecting BCR-ABL transcripts to Japan, which may open new windows for molecular assessment of CML patients in Japan.
dc.description.statementofresponsibilityChikashi Yoshida, Linda Fletcher, Kazuteru Ohashi, Hisashi Wakita, Takashi Kumagai, Masayuki Shiseki, Kousei Matsuei, Koiti Inokuchi, Yoshihiro Hatta, Yukari Shirasugi, Toshikazu Yamaguchi, Junichi Sakamoto, Susan Branford, Hisashi Sakamaki
dc.identifier.citationInternational Journal of Clinical Oncology, 2012; 17(6):584-589
dc.identifier.doi10.1007/s10147-011-0328-x
dc.identifier.issn1341-9625
dc.identifier.issn1437-7772
dc.identifier.orcidBranford, S. [0000-0002-1964-3626] [0000-0002-5095-7981]
dc.identifier.urihttp://hdl.handle.net/2440/91910
dc.language.isoen
dc.publisherSpringer Japan
dc.rights© Japan Society of Clinical Oncology 2011
dc.source.urihttps://doi.org/10.1007/s10147-011-0328-x
dc.subjectChronic myeloid leukemia; BCR-ABL; Real-time quantitative PCR; International scale; Conversion factor
dc.titleHarmonization of molecular monitoring of chronic myeloid leukemia therapy in Japan
dc.typeJournal article
pubs.publication-statusPublished

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