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3 results on '"Talmaci, R."'

1. A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR

Author

Van Der Velden, V H J, Cayuela, J-M, McCarron, S, Sacha, T, Fletcher, L, Ziermann, J, Müller, M C, Schimmel, H, El Housni, H, White, H, Farrugia, J, Boeckx, N, Romeo, G, Johnels, P, Zoi, K, Chudleigh, S, Lion, T, Kairisto, V, Deprez, L, Ganderton, R, Merle, P A, Dulucq, S, Pajič, T, Gerrard, G, Martinelli, G, Trapmann, S, Hall, V, Nagar, M, Colomer, D, Hochhaus, A, Kizilors, A, Mitterbauer-Hohendanner, G, Talmaci, R, Gineikienė, E, Oppliger Leibundgut, Elisabeth, Mazoua, S, Cross, N C P, Milner, B, Zadro, R, Lin, F, Foroni, L, Waits, P, Kim, D-W, Nickless, G, Jansson, M, Pfeifer, H, Wilson, G, Raudsepp, K, Clench, T, Daraio, F, Preudhomme, C, Wang, L, Emons, H, Bench, A, Nomdedéu, J, Wilkinson, E, Hayette, S, Jurcek, T, Aggerholm, A, Izzo, B, Lange, T, Akiki, S, Andrikovics, H, Polakova, K M, Corbisier, P, Ozbek, U, Nymoen, D A, Wren, D, Barbany, G, Catherwood, M, and Touloumenidou, T

Subjects
hemic and lymphatic diseases, 610 Medicine & health, 3. Good health
Abstract

Serial quantification of BCR-ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukaemia, but there is a substantial variation in results reported by different laboratories. To improve comparability, an internationally accepted plasmid certified reference material (CRM) was developed according to ISO Guide 34:2009. Fragments of BCR-ABL1 (e14a2 mRNA fusion), BCR and GUSB transcripts were amplified and cloned into pUC18 to yield plasmid pIRMM0099. Six different linearised plasmid solutions were produced with the following copy number concentrations, assigned by digital PCR, and expanded uncertainties: 1.08±0.13 × 10(6), 1.08±0.11 × 10(5), 1.03±0.10 × 10(4), 1.02±0.09 × 10(3), 1.04±0.10 × 10(2) and 10.0±1.5 copies/μl. The certification of the material for the number of specific DNA fragments per plasmid, copy number concentration of the plasmid solutions and the assessment of inter-unit heterogeneity and stability were performed according to ISO Guide 35:2006. Two suitability studies performed by 63 BCR-ABL1 testing laboratories demonstrated that this set of 6 plasmid CRMs can help to standardise a number of measured transcripts of e14a2 BCR-ABL1 and three control genes (ABL1, BCR and GUSB). The set of six plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (https://ec.europa.eu/jrc/en/reference-materials/catalogue/; CRM code ERM-AD623a-f).

2. A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR

Author

J M Cayuela, BJ Milner, Stéphane Mazoua, Elisabeth Oppliger Leibundgut, Linda Fletcher, Heike Pfeifer, Tomáš Jurček, E Gineikienė, P. Waits, Susanna Akiki, G Wilson, J Farrugia, H El Housni, Ugur Ozbek, D Wren, F. Lin, Tomasz Sacha, Hajnalka Andrikovics, S Chudleigh, Letizia Foroni, Stefanie Trapmann, Petra Johnels, Gareth Gerrard, Thomas Lion, M. Jansson, Katerina Zoi, Hendrik Emons, K. Raudsepp, Gisela Barbany, D A Nymoen, H Schimmel, J Ziermann, Nancy Boeckx, Mark Catherwood, Sandrine Hayette, G Romeo, Helen E. White, R Ganderton, Filomena Daraio, G. Mitterbauer-Hohendanner, Philippe Corbisier, Claude Preudhomme, Andreas Hochhaus, Martin C. Müller, P A Merle, V H J van der Velden, M Nagar, Victoria J. Hall, Lihui Wang, Theis Lange, Tim Clench, T Pajič, Stéphanie Dulucq, D-W Kim, Nicholas C.P. Cross, Josep F. Nomdedeu, Rodica Talmaci, Kateřina Machová Poláková, A Bench, Liesbet Deprez, T Touloumenidou, G Nickless, Veli Kairisto, Barbara Izzo, Dolors Colomer, Aytug Kizilors, Giovanni Martinelli, Renata Zadro, Anni Aggerholm, S McCarron, E Wilkinson, Hematology, CCA - Disease profiling, White, H, Deprez, L, Corbisier, P, Hall, V, Lin, F, Mazoua, S, Trapmann, S, Aggerholm, A, Andrikovics, H, Akiki, S, Barbany, G, Boeckx, N, Bench, A, Catherwood, M, Cayuela, Jm, Chudleigh, S, Clench, T, Colomer, D, Daraio, F, Dulucq, S, Farrugia, J, Fletcher, L, Foroni, L, Ganderton, R, Gerrard, G, Gineikienė, E, Hayette, S, El Housni, H, Izzo, Barbara, Jansson, M, Johnels, P, Jurcek, T, Kairisto, V, Kizilors, A, Kim, Dw, Lange, T, Lion, T, Polakova, Km, Martinelli, G, Mccarron, S, Merle, Pa, Milner, B, Mitterbauer Hohendanner, G, Nagar, M, Nickless, G, Nomdedéu, J, Nymoen, Da, Leibundgut, Eo, Ozbek, U, Pajič, T, Pfeifer, H, Preudhomme, C, Raudsepp, K, Romeo, G, Sacha, T, Talmaci, R, Touloumenidou, T, Van der Velden, Vh, Waits, P, Wang, L, Wilkinson, E, Wilson, G, Wren, D, Zadro, R, Ziermann, J, Zoi, K, Müller, Mc, Hochhaus, A, Schimmel, H, Cross, Nc, Emons, H., Immunology, Radiology & Nuclear Medicine, Izzo, B, and Mitterbauer-Hohendanner, G

Subjects
EMTREE drug terms: plasmid DNA EMTREE medical terms: Article, Cancer Research, Fusion Proteins, bcr-abl, Gene Dosage, Membrane Transport Protein, Plasmid, RECOMMENDATIONS, real time quantitative polymerase chain reaction, K562 cell line, law.invention, law, hemic and lymphatic diseases, Escherichia coli Protein, CANCER PROGRAM, Digital polymerase chain reaction, Cloning, Molecular, Polymerase chain reaction, MOLECULAR RESPONSE, Medicine (all), Escherichia coli Proteins, copy number variation, breakpoint cluster region, gene control, Hematology, Reference Standards, gusb gene, 3. Good health, Real-time polymerase chain reaction, Certified reference materials, priority journal, Oncology, real time polymerase chain reaction, Calibration, Proto-Oncogene Proteins c-bcr, Original Article, Life Sciences & Biomedicine, Medical Genetics, Plasmids, EUROPE, POLYMERASE-CHAIN-REACTION, 610 Medicine & health, Biology, Real-Time Polymerase Chain Reaction, IMATINIB, Gene dosage, Anesthésiologie, chronic myeloid leukemia, TRANSCRIPTS, TYROSINE KINASE INHIBITORS, bcr abl gene, Humans, controlled study, human, ddc:610, RNA, Messenger, CHRONIC MYELOID-LEUKEMIA, gene, certified plasmid reference material, bcr-abl1, Medicinsk genetik, freeze thawing, Messenger RNA, Science & Technology, human cell, reference value, Membrane Transport Proteins, HL 60 cell line, DNA, ta3122, Molecular biology, Cancérologie, Anesthesiology and Pain Medicine, certified reference material, minimal residual disease, Reference Standard, Hématologie
Abstract

Serial quantification of BCR-ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukaemia, but there is a substantial variation in results reported by different laboratories. To improve comparability, an internationally accepted plasmid certified reference material (CRM) was developed according to ISO Guide 34:2009. Fragments of BCR-ABL1 (e14a2 mRNA fusion), BCR and GUSB transcripts were amplified and cloned into pUC18 to yield plasmid pIRMM0099. Six different linearised plasmid solutions were produced with the following copy number concentrations, assigned by digital PCR, and expanded uncertainties: 1.08±0.13 × 10 6, 1.08±0.11 × 10 5, 1.03±0.10 × 10 4, 1.02±0.09 × 10 3, 1.04±0.10 × 10 2 and 10.0±1.5 copies/μl. The certification of the material for the number of specific DNA fragments per plasmid, copy number concentration of the plasmid solutions and the assessment of inter-unit heterogeneity and stability were performed according to ISO Guide 35:2006. Two suitability studies performed by 63 BCR-ABL1 testing laboratories demonstrated that this set of 6 plasmid CRMs can help to standardise a number of measured transcripts of e14a2 BCR-ABL1 and three control genes (ABL1, BCR and GUSB). The set of six plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (https://ec.europa.eu/jrc/en/reference-materials/catalogue/; CRM code ERM-AD623a-f)., 0, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2015

3. Laboratory recommendations for scoring deep molecular responses following treatment for chronic myeloid leukemia

Author

Thoralf Lange, K Machova Polakova, Enrico Gottardi, Tomasz Sacha, Nicholas C.P. Cross, Stéphanie Dulucq, Hans Ehrencrona, Fabrizio Pane, Letizia Foroni, Gisela Barbany, Rodica Talmaci, E. Oppliger Leibundgut, Andreas Hochhaus, Helen E. White, Martin C. Müller, Niels Pallisgaard, Barbara Izzo, Dolors Colomer, Giuseppe Saglio, Giovanni Martinelli, Thomas Lion, Cross, N C P, White, H E, Colomer, D, Ehrencrona, H, Foroni, L, Gottardi, E, Lange, T, Lion, T, Machova Polakova, K, Dulucq, S, Martinelli, G, Oppliger Leibundgut, E, Pallisgaard, N, Barbany, G, Sacha, T, Talmaci, R, Izzo, B, Saglio, G, Pane, F, Müller, M C, Hochhaus, A, Bristol Myers Squibb, N. C. P., Cro, H., White, D., Colomer, H., Ehrencrona, L., Foroni, E., Gottardi, T., Lange, T., Lion, K. M., Polakova, S., Dulucq, G., Martinelli, E. O., Leibundgut, N., Pallisgaard, G., Barbany, T., Sacha, R., Talmaci, Izzo, Barbara, G., Saglio, Pane, Fabrizio, M. C., Muller, and A., Hochhaus

Subjects
Oncology, Cancer Research, bcr-abl, Fusion Proteins, bcr-abl, Disease, Review, Bioinformatics, Polymerase Chain Reaction, Limit of Detection, hemic and lymphatic diseases, Protein-Tyrosine Kinase, CANCER PROGRAM, Chronic, 610 Medicine & health, MINIMAL RESIDUAL DISEASE POLYMERASE-CHAIN-REACTION HARMONIZING CURRENT METHODOLOGY CHRONIC MYELOGENOUS LEUKEMIA BCR-ABL TRANSCRIPTS INTERNATIONAL SCALE CANCER PROGRAM PCR IMATINIB STANDARDIZATION, Leukemic, Leukemia, Hematology, Gene Expression Regulation, Leukemic, HARMONIZING CURRENT METHODOLOGY, CHRONIC MYELOGENOUS LEUKEMIA, Myeloid leukemia, Protein-Tyrosine Kinases, BCR-ABL TRANSCRIPTS, Europe, PCR, Treatment Outcome, Calibration, Life Sciences & Biomedicine, medicine.drug, Human, medicine.medical_specialty, POLYMERASE-CHAIN-REACTION, Immunology, MINIMAL RESIDUAL DISEASE, Reproducibility of Result, IMATINIB, Myelogenous, chronic myeloid leukemia, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, medicine, Humans, Science & Technology, INTERNATIONAL SCALE, business.industry, Gene Expression Profiling, Fusion Proteins, Reproducibility of Results, Genetic Variation, 1103 Clinical Sciences, Imatinib, STANDARDIZATION, medicine.disease, Minimal residual disease, Anesthesiology and Pain Medicine, Gene Expression Regulation, Cancer and Oncology, BCR-ABL Positive, business, 1112 Oncology And Carcinogenesis, Chronic myelogenous leukemia
Abstract

Treatment of chronic myeloid leukemia (CML) with tyrosine kinase inhibitors has advanced to a stage where many patients achieve very low or undetectable levels of disease. Remarkably, some of these patients remain in sustained remission when treatment is withdrawn, suggesting that they may be at least operationally cured of their disease. Accurate definition of deep molecular responses (MRs) is therefore increasingly important for optimal patient management and comparison of independent data sets. We previously published proposals for broad standardized definitions of MR at different levels of sensitivity. Here we present detailed laboratory recommendations, developed as part of the European Treatment and Outcome Study for CML (EUTOS), to enable testing laboratories to score MR in a reproducible manner for CML patients expressing the most common BCR-ABL1 variants.Leukemia advance online publication, 27 February 2015; doi:10.1038/leu.2015.29.

Published
2015

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