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3. Long-term safety and efficacy of lentiviral hematopoietic stem/progenitor cell gene therapy for Wiskott–Aldrich syndrome

Author

Magnani, A., Semeraro, M., Adam, F., Booth, C., Dupré, L., Morris, E. C., Gabrion, A., Roudaut, C., Borgel, D., Toubert, A., Clave, E., Abdo, C., Gorochov, G., Petermann, R., Guiot, M., Miyara, M., Moshous, D., Magrin, E., Denis, A., Suarez, F., Lagresle, C., Roche, A. M., Everett, J., Trinquand, A., Guisset, M., Bayford, J. Xu, Hacein-Bey-Abina, S., Kauskot, A., Elfeky, R., Rivat, C., Abbas, S., Gaspar, H. B., Macintyre, E., Picard, C., Bushman, F. D., Galy, A., Fischer, A., Six, E., Thrasher, A. J., and Cavazzana, M.

Published
2022
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4. Author Correction: Long-term safety and efficacy of lentiviral hematopoietic stem/progenitor cell gene therapy for Wiskott–Aldrich syndrome

Author

Magnani, A., Semeraro, M., Adam, F., Booth, C., Dupré, L., Morris, E. C., Gabrion, A., Roudaut, C., Borgel, D., Toubert, A., Clave, E., Abdo, C., Gorochov, G., Petermann, R., Guiot, M., Miyara, M., Moshous, D., Magrin, E., Denis, A., Suarez, F., Lagresle, C., Roche, A. M., Everett, J., Trinquand, A., Guisset, M., Bayford, J. Xu, Hacein-Bey-Abina, S., Kauskot, A., Elfeky, R., Rivat, C., Abbas, S., Gaspar, H. B., Macintyre, E., Picard, C., Bushman, F. D., Galy, A., Fischer, A., Six, E., Thrasher, A. J., and Cavazzana, M.

Published
2022
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6. LMO2-Associated Clonal T Cell Proliferation in Two Patients after Gene Therapy for SCID-X1

Author

Von Kalle, C., Schmidt, M., McCormack, M. P., Wulffraat, N., Leboulch, P., Lim, A., Osborne, C. S., Pawliuk, R., Morillon, E., Sorensen, R., Forster, A., Fraser, P., Cohen, J. I., Alexander, I., Wintergerst, U., Frebourg, T., Aurias, A., Stoppa-Lyonnet, D., Romana, S., Radford-Weiss, I., Gross, F., Valensi, F., Delabesse, E., Macintyre, E., Sigaux, F., Soulier, J., Leiva, L. E., Wissler, M., Prinz, C., Rabbitts, T. H., Le Deist, F., Fischer, A., and Cavazzana-Calvo, M.

Published
2003

8. The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality.

Author

Horgan, D., Plebani, M., Orth, M., Macintyre, E., Jackson, S., Lal, J.A., Dube, F., Kozaric, M., Tumiene, B., Salgado, R., Schalken, J.A., Capoluongo, E.D., Carnielli, M., Horgan, D., Plebani, M., Orth, M., Macintyre, E., Jackson, S., Lal, J.A., Dube, F., Kozaric, M., Tumiene, B., Salgado, R., Schalken, J.A., Capoluongo, E.D., and Carnielli, M.

Abstract

Item does not contain fulltext, The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways.

Published
2023

12. Validation of the EuroClonality-NGS DNA capture panel as an integrated genomic tool for lymphoproliferative disorders

Author

Stewart, J, Gazdova, J, Darzentas, N, Wren, D, Proszek, P, Fazio, G, Songia, S, Alcoceba, M, Sarasquete, M, Villarese, P, Van Der Klift, M, Heezen, K, Mccafferty, N, Pal, K, Catherwood, M, Kim, C, Srivastava, S, Kroeze, L, Hodges, E, Stamatopoulos, K, Klapper, W, Genuardi, E, Ferrero, S, Van Den Brand, M, Cazzaniga, G, Davi, F, Sutton, L, Garcia-Sanz, R, Groenen, P, Macintyre, E, Bruggemann, M, Pott, C, Langerak, A, Gonzalez, D, Stewart J. P., Gazdova J., Darzentas N., Wren D., Proszek P., Fazio G., Songia S., Alcoceba M., Sarasquete M. E., Villarese P., Van Der Klift M. Y., Heezen K. C., McCafferty N., Pal K., Catherwood M., Kim C. S., Srivastava S., Kroeze L. I., Hodges E., Stamatopoulos K., Klapper W., Genuardi E., Ferrero S., Van Den Brand M., Cazzaniga G., Davi F., Sutton L. -A., Garcia-Sanz R., Groenen P. J. T. A., Macintyre E. A., Bruggemann M., Pott C., Langerak A. W., Gonzalez D., Stewart, J, Gazdova, J, Darzentas, N, Wren, D, Proszek, P, Fazio, G, Songia, S, Alcoceba, M, Sarasquete, M, Villarese, P, Van Der Klift, M, Heezen, K, Mccafferty, N, Pal, K, Catherwood, M, Kim, C, Srivastava, S, Kroeze, L, Hodges, E, Stamatopoulos, K, Klapper, W, Genuardi, E, Ferrero, S, Van Den Brand, M, Cazzaniga, G, Davi, F, Sutton, L, Garcia-Sanz, R, Groenen, P, Macintyre, E, Bruggemann, M, Pott, C, Langerak, A, Gonzalez, D, Stewart J. P., Gazdova J., Darzentas N., Wren D., Proszek P., Fazio G., Songia S., Alcoceba M., Sarasquete M. E., Villarese P., Van Der Klift M. Y., Heezen K. C., McCafferty N., Pal K., Catherwood M., Kim C. S., Srivastava S., Kroeze L. I., Hodges E., Stamatopoulos K., Klapper W., Genuardi E., Ferrero S., Van Den Brand M., Cazzaniga G., Davi F., Sutton L. -A., Garcia-Sanz R., Groenen P. J. T. A., Macintyre E. A., Bruggemann M., Pott C., Langerak A. W., and Gonzalez D.

Abstract

Current diagnostic standards for lymphoproliferative disorders include multiple tests for detection of clonal immunoglobulin (IG) and/or T-cell receptor (TCR) rearrangements, translocations, copy-number alterations (CNAs), and somatic mutations. The EuroClonality-NGS DNA Capture (EuroClonality-NDC) assay was designed as an integrated tool to characterize these alterations by capturing IGH switch regions along with variable, diversity, and joining genes of all IG and TCR loci in addition to clinically relevant genes for CNA and mutation analysis. Diagnostic performance against standard-of-care clinical testing was assessed in a cohort of 280 B-and T-cell malignancies from 10 European laboratories, including 88 formalin-fixed paraffin-embedded samples and 21 reactive lesions. DNA samples were subjected to the EuroClonality-NDC protocol in 7 EuroClonality-NGS laboratories and analyzed using a bespoke bioinformatic pipeline. The EuroClonality-NDC assay detected B-cell clonality in 191 (97%) of 197 B-cell malignancies and T-cell clonality in 71 (97%) of 73 T-cell malignancies. Limit of detection (LOD) for IG/TCR rearrangements was established at 5% using cell line blends. Chromosomal translocations were detected in 145 (95%) of 152 cases known to be positive. CNAs were validated for immunogenetic and oncogenetic regions, highlighting their novel role in confirming clonality in somatically hypermutated cases. Single-nucleotide variant LOD was determined as 4% allele frequency, and an orthogonal validation using 32 samples resulted in 98% concordance. The EuroClonality-NDC assay is a robust tool providing a single end-To-end workflow for simultaneous detection of B-and T-cell clonality, translocations, CNAs, and sequence variants.

Published
2021

14. The International Consensus Classification of Mature Lymphoid Neoplasms: a report from the Clinical Advisory Committee

Author

Campo, E., Jaffe, E.S., Cook, J.R., Quintanilla-Martinez, L., Swerdlow, S.H., Anderson, K.C., Brousset, P., Cerroni, L., de Leval, L., Dirnhofer, S., Dogan, A., Feldman, A.L., Fend, F., Friedberg, J.W., Gaulard, P., Ghia, P., Horwitz, S.M., King, R.L., Salles, G., San-Miguel, J., Seymour, J.F., Treon, S.P., Vose, J.M., Zucca, E., Advani, R., Ansell, S., Au, W.Y., Barrionuevo, C., Bergsagel, L., Chan, W.C., Cohen, J.I., d'Amore, F., Davies, A., Falini, B., Ghobrial, I.M., Goodlad, J.R., Gribben, J.G., Hsi, E.D., Kahl, B.S., Kim, W.S., Kumar, S., LaCasce, A.S., Laurent, C., Lenz, G., Leonard, J.P., Link, M.P., Lopez-Guillermo, A., Mateos, M.V., Macintyre, E., Melnick, A.M., Morschhauser, F., Nakamura, S., Narbaitz, M., Pavlovsky, A., Pileri, S.A., Piris, M., Pro, B., Rajkumar, V., Rosen, S.T., Sander, B., Sehn, L., Shipp, M.A., Smith, S.M., Staudt, L.M., Thieblemont, C., Tousseyn, T., Wilson, W.H., Yoshino, T., Zinzani, P.L., Dreyling, M., Scott, D.W., Winter, J.N., and Zelenetz, A.D.

Subjects
Advisory Committees, Consensus, Hematologic Neoplasms/diagnosis, Hematologic Neoplasms/genetics, Humans, Lymphoma/pathology, World Health Organization
Abstract

Since the publication of the Revised European-American Classification of Lymphoid Neoplasms in 1994, subsequent updates of the classification of lymphoid neoplasms have been generated through iterative international efforts to achieve broad consensus among hematopathologists, geneticists, molecular scientists, and clinicians. Significant progress has recently been made in the characterization of malignancies of the immune system, with many new insights provided by genomic studies. They have led to this proposal. We have followed the same process that was successfully used for the third and fourth editions of the World Health Organization Classification of Hematologic Neoplasms. The definition, recommended studies, and criteria for the diagnosis of many entities have been extensively refined. Some categories considered provisional have now been upgraded to definite entities. Terminology for some diseases has been revised to adapt nomenclature to the current knowledge of their biology, but these modifications have been restricted to well-justified situations. Major findings from recent genomic studies have impacted the conceptual framework and diagnostic criteria for many disease entities. These changes will have an impact on optimal clinical management. The conclusions of this work are summarized in this report as the proposed International Consensus Classification of mature lymphoid, histiocytic, and dendritic cell tumors.

Published
2022

16. The International Consensus Classification of Mature Lymphoid Neoplasms: a report from the Clinical Advisory Committee

Author

Campo, E, Jaffe, ES, Cook, JR, Quintanilla-Martinez, L, Swerdlow, SH, Anderson, KC, Brousset, P, Cerroni, L, de Leval, L, Dirnhofer, S, Dogan, A, Feldman, AL, Fend, F, Friedberg, JW, Gaulard, P, Ghia, P, Horwitz, SM, King, RL, Salles, G, San-Miguel, J, Seymour, JF, Treon, SP, Vose, JM, Zucca, E, Advani, R, Ansell, S, Au, W-Y, Barrionuevo, C, Bergsagel, L, Chan, WC, Cohen, JI, d'Amore, F, Davies, A, Falini, B, Ghobrial, IM, Goodlad, JR, Gribben, JG, Hsi, ED, Kahl, BS, Kim, W-S, Kumar, S, LaCasce, AS, Laurent, C, Lenz, G, Leonard, JP, Link, MP, Lopez-Guillermo, A, Mateos, MV, Macintyre, E, Melnick, AM, Morschhauser, F, Nakamura, S, Narbaitz, M, Pavlovsky, A, Pileri, SA, Piris, M, Pro, B, Rajkumar, V, Rosen, ST, Sander, B, Sehn, L, Shipp, MA, Smith, SM, Staudt, LM, Thieblemont, C, Tousseyn, T, Wilson, WH, Yoshino, T, Zinzani, P-L, Dreyling, M, Scott, DW, Winter, JN, Zelenetz, A, Campo, E, Jaffe, ES, Cook, JR, Quintanilla-Martinez, L, Swerdlow, SH, Anderson, KC, Brousset, P, Cerroni, L, de Leval, L, Dirnhofer, S, Dogan, A, Feldman, AL, Fend, F, Friedberg, JW, Gaulard, P, Ghia, P, Horwitz, SM, King, RL, Salles, G, San-Miguel, J, Seymour, JF, Treon, SP, Vose, JM, Zucca, E, Advani, R, Ansell, S, Au, W-Y, Barrionuevo, C, Bergsagel, L, Chan, WC, Cohen, JI, d'Amore, F, Davies, A, Falini, B, Ghobrial, IM, Goodlad, JR, Gribben, JG, Hsi, ED, Kahl, BS, Kim, W-S, Kumar, S, LaCasce, AS, Laurent, C, Lenz, G, Leonard, JP, Link, MP, Lopez-Guillermo, A, Mateos, MV, Macintyre, E, Melnick, AM, Morschhauser, F, Nakamura, S, Narbaitz, M, Pavlovsky, A, Pileri, SA, Piris, M, Pro, B, Rajkumar, V, Rosen, ST, Sander, B, Sehn, L, Shipp, MA, Smith, SM, Staudt, LM, Thieblemont, C, Tousseyn, T, Wilson, WH, Yoshino, T, Zinzani, P-L, Dreyling, M, Scott, DW, Winter, JN, and Zelenetz, A

Abstract

Since the publication of the Revised European-American Classification of Lymphoid Neoplasms in 1994, subsequent updates of the classification of lymphoid neoplasms have been generated through iterative international efforts to achieve broad consensus among hematopathologists, geneticists, molecular scientists, and clinicians. Significant progress has recently been made in the characterization of malignancies of the immune system, with many new insights provided by genomic studies. They have led to this proposal. We have followed the same process that was successfully used for the third and fourth editions of the World Health Organization Classification of Hematologic Neoplasms. The definition, recommended studies, and criteria for the diagnosis of many entities have been extensively refined. Some categories considered provisional have now been upgraded to definite entities. Terminology for some diseases has been revised to adapt nomenclature to the current knowledge of their biology, but these modifications have been restricted to well-justified situations. Major findings from recent genomic studies have impacted the conceptual framework and diagnostic criteria for many disease entities. These changes will have an impact on optimal clinical management. The conclusions of this work are summarized in this report as the proposed International Consensus Classification of mature lymphoid, histiocytic, and dendritic cell tumors.

Published
2022

17. Quality control and quantification in IG/TR next-generation sequencing marker identification: protocols and bioinformatic functionalities by EuroClonality-NGS

Author

Knecht, H, Reigl, T, Kotrova, M, Appelt, F, Stewart, P, Bystry, V, Krejci, A, Grioni, A, Pal, K, Stranska, K, Plevova, K, Rijntjes, J, Songia, S, Svaton, M, Fronkova, E, Bartram, J, Scheijen, B, Herrmann, D, Garcia-Sanz, R, Hancock, J, Moppett, J, van Dongen, J, Cazzaniga, G, Davi, F, Groenen, P, Hummel, M, Macintyre, E, Stamatopoulos, K, Trka, J, Langerak, A, Gonzalez, D, Pott, C, Bruggemann, M, Darzentas, N, Knecht H., Reigl T., Kotrova M., Appelt F., Stewart P., Bystry V., Krejci A., Grioni A., Pal K., Stranska K., Plevova K., Rijntjes J., Songia S., Svaton M., Fronkova E., Bartram J., Scheijen B., Herrmann D., Garcia-Sanz R., Hancock J., Moppett J., van Dongen J. J. M., Cazzaniga G., Davi F., Groenen P. J. T. A., Hummel M., Macintyre E. A., Stamatopoulos K., Trka J., Langerak A. W., Gonzalez D., Pott C., Bruggemann M., Darzentas N., Knecht, H, Reigl, T, Kotrova, M, Appelt, F, Stewart, P, Bystry, V, Krejci, A, Grioni, A, Pal, K, Stranska, K, Plevova, K, Rijntjes, J, Songia, S, Svaton, M, Fronkova, E, Bartram, J, Scheijen, B, Herrmann, D, Garcia-Sanz, R, Hancock, J, Moppett, J, van Dongen, J, Cazzaniga, G, Davi, F, Groenen, P, Hummel, M, Macintyre, E, Stamatopoulos, K, Trka, J, Langerak, A, Gonzalez, D, Pott, C, Bruggemann, M, Darzentas, N, Knecht H., Reigl T., Kotrova M., Appelt F., Stewart P., Bystry V., Krejci A., Grioni A., Pal K., Stranska K., Plevova K., Rijntjes J., Songia S., Svaton M., Fronkova E., Bartram J., Scheijen B., Herrmann D., Garcia-Sanz R., Hancock J., Moppett J., van Dongen J. J. M., Cazzaniga G., Davi F., Groenen P. J. T. A., Hummel M., Macintyre E. A., Stamatopoulos K., Trka J., Langerak A. W., Gonzalez D., Pott C., Bruggemann M., and Darzentas N.

Abstract

Assessment of clonality, marker identification and measurement of minimal residual disease (MRD) of immunoglobulin (IG) and T cell receptor (TR) gene rearrangements in lymphoid neoplasms using next-generation sequencing (NGS) is currently under intensive development for use in clinical diagnostics. So far, however, there is a lack of suitable quality control (QC) options with regard to standardisation and quality metrics to ensure robust clinical application of such approaches. The EuroClonality-NGS Working Group has therefore established two types of QCs to accompany the NGS-based IG/TR assays. First, a central polytarget QC (cPT-QC) is used to monitor the primer performance of each of the EuroClonality multiplex NGS assays; second, a standardised human cell line-based DNA control is spiked into each patient DNA sample to work as a central in-tube QC and calibrator for MRD quantification (cIT-QC). Having integrated those two reference standards in the ARResT/Interrogate bioinformatic platform, EuroClonality-NGS provides a complete protocol for standardised IG/TR gene rearrangement analysis by NGS with high reproducibility, accuracy and precision for valid marker identification and quantification in diagnostics of lymphoid malignancies.

Published
2019

18. Standardized next-generation sequencing of immunoglobulin and T-cell receptor gene recombinations for MRD marker identification in acute lymphoblastic leukaemia; a EuroClonality-NGS validation study

Author

Bruggemann, M, Kotrova, M, Knecht, H, Bartram, J, Boudjogrha, M, Bystry, V, Fazio, G, Fronkova, E, Giraud, M, Grioni, A, Hancock, J, Herrmann, D, Jimenez, C, Krejci, A, Moppett, J, Reigl, T, Salson, M, Scheijen, B, Schwarz, M, Songia, S, Svaton, M, van Dongen, J, Villarese, P, Wakeman, S, Wright, G, Cazzaniga, G, Davi, F, Garcia-Sanz, R, Gonzalez, D, Groenen, P, Hummel, M, Macintyre, E, Stamatopoulos, K, Pott, C, Trka, J, Darzentas, N, Langerak, A, Bruggemann M., Kotrova M., Knecht H., Bartram J., Boudjogrha M., Bystry V., Fazio G., Fronkova E., Giraud M., Grioni A., Hancock J., Herrmann D., Jimenez C., Krejci A., Moppett J., Reigl T., Salson M., Scheijen B., Schwarz M., Songia S., Svaton M., van Dongen J. J. M., Villarese P., Wakeman S., Wright G., Cazzaniga G., Davi F., Garcia-Sanz R., Gonzalez D., Groenen P. J. T. A., Hummel M., Macintyre E. A., Stamatopoulos K., Pott C., Trka J., Darzentas N., Langerak A. W., Bruggemann, M, Kotrova, M, Knecht, H, Bartram, J, Boudjogrha, M, Bystry, V, Fazio, G, Fronkova, E, Giraud, M, Grioni, A, Hancock, J, Herrmann, D, Jimenez, C, Krejci, A, Moppett, J, Reigl, T, Salson, M, Scheijen, B, Schwarz, M, Songia, S, Svaton, M, van Dongen, J, Villarese, P, Wakeman, S, Wright, G, Cazzaniga, G, Davi, F, Garcia-Sanz, R, Gonzalez, D, Groenen, P, Hummel, M, Macintyre, E, Stamatopoulos, K, Pott, C, Trka, J, Darzentas, N, Langerak, A, Bruggemann M., Kotrova M., Knecht H., Bartram J., Boudjogrha M., Bystry V., Fazio G., Fronkova E., Giraud M., Grioni A., Hancock J., Herrmann D., Jimenez C., Krejci A., Moppett J., Reigl T., Salson M., Scheijen B., Schwarz M., Songia S., Svaton M., van Dongen J. J. M., Villarese P., Wakeman S., Wright G., Cazzaniga G., Davi F., Garcia-Sanz R., Gonzalez D., Groenen P. J. T. A., Hummel M., Macintyre E. A., Stamatopoulos K., Pott C., Trka J., Darzentas N., and Langerak A. W.

Abstract

Amplicon-based next-generation sequencing (NGS) of immunoglobulin (IG) and T-cell receptor (TR) gene rearrangements for clonality assessment, marker identification and quantification of minimal residual disease (MRD) in lymphoid neoplasms has been the focus of intense research, development and application. However, standardization and validation in a scientifically controlled multicentre setting is still lacking. Therefore, IG/TR assay development and design, including bioinformatics, was performed within the EuroClonality-NGS working group and validated for MRD marker identification in acute lymphoblastic leukaemia (ALL). Five EuroMRD ALL reference laboratories performed IG/TR NGS in 50 diagnostic ALL samples, and compared results with those generated through routine IG/TR Sanger sequencing. A central polytarget quality control (cPT-QC) was used to monitor primer performance, and a central in-tube quality control (cIT-QC) was spiked into each sample as a library-specific quality control and calibrator. NGS identified 259 (average 5.2/sample, range 0–14) clonal sequences vs. Sanger-sequencing 248 (average 5.0/sample, range 0–14). NGS primers covered possible IG/TR rearrangement types more completely compared with local multiplex PCR sets and enabled sequencing of bi-allelic rearrangements and weak PCR products. The cPT-QC showed high reproducibility across all laboratories. These validated and reproducible quality-controlled EuroClonality-NGS assays can be used for standardized NGS-based identification of IG/TR markers in lymphoid malignancies.

Published
2019

19. Flow cytometry and IG/TCR quantitative PCR for minimal residual disease quantitation in acute lymphoblastic leukemia: a French multicenter prospective study on behalf of the FRALLE, EORTC and GRAALL

Author

Garand, R, Beldjord, K, Cavé, H, Fossat, C, Arnoux, I, Asnafi, V, Bertrand, Y, Boulland, M-L, Brouzes, C, Clappier, E, Delabesse, E, Fest, T, Garnache-Ottou, F, Huguet, F, Jacob, M-C, Kuhlein, E, Marty-Grès, S, Plesa, A, Robillard, N, Roussel, M, Tkaczuk, J, Dombret, H, Macintyre, E, Ifrah, N, Béné, M C, and Baruchel, A

Published
2013
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21. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis

Author

Stanton, TR, Braithwaite, FA, Butler, D, Moseley, GL, Hill, C, Milte, R, Ratcliffe, J, Maher, C, Tomkins-Lane, C, Pulling, BW, MacIntyre, E, Esterman, A, Stanford, T, Lee, H, Fraysse, F, Metcalf, B, Mouatt, B, Bennell, K, Stanton, TR, Braithwaite, FA, Butler, D, Moseley, GL, Hill, C, Milte, R, Ratcliffe, J, Maher, C, Tomkins-Lane, C, Pulling, BW, MacIntyre, E, Esterman, A, Stanford, T, Lee, H, Fraysse, F, Metcalf, B, Mouatt, B, and Bennell, K

Abstract

BACKGROUND: Despite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program. METHODS: Two-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environm

Published
2021

23. Standardized MRD quantification in European ALL trials: Proceedings of the Second International Symposium on MRD assessment in Kiel, Germany, 18–20 September 2008

Author

Brüggemann, M, Schrauder, A, Raff, T, Pfeifer, H, Dworzak, M, Ottmann, O G, Asnafi, V, Baruchel, A, Bassan, R, Benoit, Y, Biondi, A, Cavé, H, Dombret, H, Fielding, A K, Foà, R, Gökbuget, N, Goldstone, A H, Goulden, N, Henze, G, Hoelzer, D, Janka-Schaub, G E, Macintyre, E A, Pieters, R, Rambaldi, A, Ribera, J-M, Schmiegelow, K, Spinelli, O, Stary, J, von Stackelberg, A, Kneba, M, Schrappe, M, and van Dongen, J J M

Published
2010
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24. PAX5 mutations occur frequently in adult B-cell progenitor acute lymphoblastic leukemia and PAX5 haploinsufficiency is associated with BCR-ABL1 and TCF3-PBX1 fusion genes: a GRAALL study

Author

Familiades, J, Bousquet, M, Lafage-Pochitaloff, M, Béné, M-C, Beldjord, K, De Vos, J, Dastugue, N, Coyaud, E, Struski, S, Quelen, C, Prade-Houdellier, N, Dobbelstein, S, Cayuela, J-M, Soulier, J, Grardel, N, Preudhomme, C, Cavé, H, Blanchet, O, Lhéritier, V, Delannoy, A, Chalandon, Y, Ifrah, N, Pigneux, A, Brousset, P, Macintyre, E A, Huguet, F, Dombret, H, Broccardo, C, and Delabesse, É

Published
2009
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25. New insights to the MLL recombinome of acute leukemias

Author

Meyer, C, Kowarz, E, Hofmann, J, Renneville, A, Zuna, J, Trka, J, Ben Abdelali, R, Macintyre, E, De Braekeleer, E, De Braekeleer, M, Delabesse, E, de Oliveira, M P, Cavé, H, Clappier, E, van Dongen, J J M, Balgobind, B V, van den Heuvel-Eibrink, M M, Beverloo, H B, Panzer-Grümayer, R, Teigler-Schlegel, A, Harbott, J, Kjeldsen, E, Schnittger, S, Koehl, U, Gruhn, B, Heidenreich, O, Chan, L C, Yip, S F, Krzywinski, M, Eckert, C, Möricke, A, Schrappe, M, Alonso, C N, Schäfer, B W, Krauter, J, Lee, D A, zur Stadt, U, Te Kronnie, G, Sutton, R, Izraeli, S, Trakhtenbrot, L, Lo Nigro, L, Tsaur, G, Fechina, L, Szczepanski, T, Strehl, S, Ilencikova, D, Molkentin, M, Burmeister, T, Dingermann, T, Klingebiel, T, and Marschalek, R

Published
2009
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26. Flow cytometric immunobead assay for the detection of BCR–ABL fusion proteins in leukemia patients

Author

Weerkamp, F, Dekking, E, Ng, Y Y, van der Velden, V H J, Wai, H, Böttcher, S, Brüggemann, M, van der Sluijs, A J, Koning, A, Boeckx, N, Van Poecke, N, Lucio, P, Mendonça, A, Sedek, L, Szczepański, T, Kalina, T, Kovac, M, Hoogeveen, P G, Flores-Montero, J, Orfao, A, Macintyre, E, Lhermitte, L, Chen, R, Brouwer-De Cock, K A J, van der Linden, A, Noordijk, A L, Comans-Bitter, W M, Staal, F J T, and van Dongen, J J M

Published
2009
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27. Characterization of a reference material for BCR-ABL (M-BCR) mRNA quantitation by real-time amplification assays: towards new standards for gene expression measurements

Author

Saldanha, J, Silvy, M, Beaufils, N, Arlinghaus, R, Barbany, G, Branford, S, Cayuela, J-M, Cazzaniga, G, Gonzalez, M, Grimwade, D, Kairisto, V, Miyamura, K, Lawler, M, Lion, T, Macintyre, E, Mahon, F-X, Muller, M C, Ostergaard, M, Pfeifer, H, Saglio, G, Sawyers, C, Spinelli, O, van der Velden, V H J, Wang, J Q, Zoi, K, Patel, V, Phillips, P, Matejtschuk, P, and Gabert, J

Published
2007
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28. Improved reliability of lymphoma diagnostics via PCR-based clonality testing: — Report of the BIOMED-2 Concerted Action BHM4-CT98-3936

Author

van Krieken, J H J M, Langerak, A W, Macintyre, E A, Kneba, M, Hodges, E, Sanz, R Garcia, Morgan, G J, Parreira, A, Molina, T J, Cabeçadas, J, Gaulard, P, Jasani, B, Garcia, J F, Ott, M, Hannsmann, M L, Berger, F, Hummel, M, Davi, F, Brüggemann, M, Lavender, F L, Schuuring, E, Evans, P A S, White, H, Salles, G, Groenen, P J T A, Gameiro, P, Pott, Ch, and Dongen, J J M van

Published
2007
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29. Allogeneic stem cell transplantation improves the outcome of adults with t(1;19)/E2A-PBX1 and t(4;11)/MLL-AF4 positive B-cell acute lymphoblastic leukemia: results of the prospective multicenter LALA-94 study

Author

Vey, N, Thomas, X, Picard, C, Kovascovicz, T, Charin, C, Cayuela, J M, Dombret, H, Dastugue, N, Huguet, F, Bastard, C, Stamatoulas, A, Giollant, M, Tournilhac, O, Macintyre, E, Buzyn, A, Bories, D, Kuentz, M, Dreyfus, F, Delannoy, A, Raynaud, S, Gratecos, N, Bordessoule, D, de Botton, S, Preudhomme, C, Reman, O, Troussard, X, Pigneux, A, Bilhou, C, Vernant, J P, Boucheix, C, and Gabert, J

Published
2006
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30. Prospective multicentric molecular study for poor prognosis fusion transcripts at diagnosis in adult B-lineage ALL patients: the LALA 94 experience

Author

Picard, C, Hayette, S, Bilhou-Nabera, C, Cayuela, J M, Delabesse, E, Frenoy, N, Preudhomme, C, Dupont, M, Bastard, C, Bories, D, Vaerman, J L, Davi, F, Dastugue, N, Raynaud, S, Lafage, M, Deschaseaux, F, Fest, T, Gaub, M P, Lhéritier, V, Thomas, X, Charrin, C, Boucheix, C, Dombret, H, MacIntyre, E, Fière, D, and Gabert, J

Published
2006
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32. The MLL recombinome of acute leukemias

Author

Meyer, C, Schneider, B, Jakob, S, Strehl, S, Attarbaschi, A, Schnittger, S, Schoch, C, Jansen, M W J C, van Dongen, J J M, den Boer, M L, Pieters, R, Ennas, M-G, Angelucci, E, Koehl, U, Greil, J, Griesinger, F, zur Stadt, U, Eckert, C, Szczepański, T, Niggli, F K, Schäfer, B W, Kempski, H, Brady, H J M, Zuna, J, Trka, J, Nigro, L L, Biondi, A, Delabesse, E, Macintyre, E, Stanulla, M, Schrappe, M, Haas, O A, Burmeister, T, Dingermann, T, Klingebiel, T, and Marschalek, R

Published
2006
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34. CBFβ-SMMHC Affects Genome-wide Polycomb Repressive Complex 1 Activity in Acute Myeloid Leukemia

Author

Cordonnier, G., Mandoli, A., Cagnard, N., Hypolite, G., Lhermitte, L., Verhoeyen, E., Asnafi, V., Dillon, N., Macintyre, E., Martens, J.H.A., Bond, J., Cordonnier, G., Mandoli, A., Cagnard, N., Hypolite, G., Lhermitte, L., Verhoeyen, E., Asnafi, V., Dillon, N., Macintyre, E., Martens, J.H.A., and Bond, J.

Abstract

Contains fulltext : 227158.pdf (publisher's version ) (Open Access), Mutations and deletions of polycomb repressive complex (PRC) components are increasingly recognized to affect tumor biology in a range of cancers. However, little is known about how genetic alterations of PRC-interacting molecules such as the core binding …

Published
2020

35. Reducing Bureaucracy in Clinical Research: A Call for Action

Author

Gribben, J, Macintyre, E, Sonneveld, Pieter, Doorduijn, Jeanette, Gisselbrecht, C, Jager, U, Le Gouill, S, Rule, S, Dreyling, M, Gribben, J, Macintyre, E, Sonneveld, Pieter, Doorduijn, Jeanette, Gisselbrecht, C, Jager, U, Le Gouill, S, Rule, S, and Dreyling, M

Published
2020

36. Constitutive Activation of RAS/MAPK Pathway Cooperates with Trisomy 21 and Is Therapeutically Exploitable in Down Syndrome B-cell Leukemia

Author

Laurent, A.P., Siret, A., Ignacimouttou, C., Panchal, K., Diop, M., Jenni, S., Tsai, Y.C., Roos-Weil, D., Aid, Z., Prade, N., Lagarde, S., Plassard, D., Pierron, G., Daudigeos, E., Lecluse, Y., Droin, N., Bornhauser, B.C., Cheung, Laurence, Crispino, J.D., Gaudry, M., Bernard, O.A., Macintyre, E., Barin Bonnigal, C., Kotecha, Rishi, Geoerger, B., Ballerini, P., Bourquin, J.P., Delabesse, E., Mercher, T., Malinge, S., Laurent, A.P., Siret, A., Ignacimouttou, C., Panchal, K., Diop, M., Jenni, S., Tsai, Y.C., Roos-Weil, D., Aid, Z., Prade, N., Lagarde, S., Plassard, D., Pierron, G., Daudigeos, E., Lecluse, Y., Droin, N., Bornhauser, B.C., Cheung, Laurence, Crispino, J.D., Gaudry, M., Bernard, O.A., Macintyre, E., Barin Bonnigal, C., Kotecha, Rishi, Geoerger, B., Ballerini, P., Bourquin, J.P., Delabesse, E., Mercher, T., and Malinge, S.

Abstract

©2020 American Association for Cancer Research. PURPOSE: Children with Down syndrome (constitutive trisomy 21) that develop acute lymphoblastic leukemia (DS-ALL) have a 3-fold increased likelihood of treatment-related mortality coupled with a higher cumulative incidence of relapse, compared with other children with B-cell acute lymphoblastic leukemia (B-ALL). This highlights the lack of suitable treatment for Down syndrome children with B-ALL. EXPERIMENTAL DESIGN: To facilitate the translation of new therapeutic agents into clinical trials, we built the first preclinical cohort of patient-derived xenograft (PDX) models of DS-ALL, comprehensively characterized at the genetic and transcriptomic levels, and have proven its suitability for preclinical studies by assessing the efficacy of drug combination between the MEK inhibitor trametinib and conventional chemotherapy agents. RESULTS: Whole-exome and RNA-sequencing experiments revealed a high incidence of somatic alterations leading to RAS/MAPK pathway activation in our cohort of DS-ALL, as well as in other pediatric B-ALL presenting somatic gain of the chromosome 21 (B-ALL+21). In murine and human B-cell precursors, activated KRASG12D functionally cooperates with trisomy 21 to deregulate transcriptional networks that promote increased proliferation and self renewal, as well as B-cell differentiation blockade. Moreover, we revealed that inhibition of RAS/MAPK pathway activation using the MEK1/2 inhibitor trametinib decreased leukemia burden in several PDX models of B-ALL+21, and enhanced survival of DS-ALL PDX in combination with conventional chemotherapy agents such as vincristine. CONCLUSIONS: Altogether, using novel and suitable PDX models, this study indicates that RAS/MAPK pathway inhibition represents a promising strategy to improve the outcome of Down syndrome children with B-cell precursor leukemia.

Published
2020

41. Design and standardization of PCR primers and protocols for detection of clonal immunoglobulin and T-cell receptor gene recombinations in suspect lymphoproliferations: Report of the BIOMED-2 Concerted Action BMH4-CT98-3936

Author

van Dongen, J J M, Langerak, A W, Brüggemann, M, Evans, P A S, Hummel, M, Lavender, F L, Delabesse, E, Davi, F, Schuuring, E, García-Sanz, R, van Krieken, J H J M, Droese, J, González, D, Bastard, C, White, H E, Spaargaren, M, González, M, Parreira, A, Smith, J L, Morgan, G J, Kneba, M, and Macintyre, E A

Published
2003
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42. The MLL recombinome of acute leukemias in 2013

Author

Meyer, C, Hofmann, J, Burmeister, T, Gröger, D, Park, T S, Emerenciano, M, Pombo de Oliveira, M, Renneville, A, Villarese, P, Macintyre, E, Cavé, H, Clappier, E, Mass-Malo, K, Zuna, J, Trka, J, De Braekeleer, E, De Braekeleer, M, Oh, S H, Tsaur, G, Fechina, L, van der Velden, V HJ, van Dongen, J JM, Delabesse, E, Binato, R, Silva, M LM, Kustanovich, A, Aleinikova, O, Harris, M H, Lund-Aho, T, Juvonen, V, Heidenreich, O, Vormoor, J, Choi, W WL, Jarosova, M, Kolenova, A, Bueno, C, Menendez, P, Wehner, S, Eckert, C, Talmant, P, Tondeur, S, Lippert, E, Launay, E, Henry, C, Ballerini, P, Lapillone, H, Callanan, M B, Cayuela, J M, Herbaux, C, Cazzaniga, G, Kakadiya, P M, Bohlander, S, Ahlmann, M, Choi, J R, Gameiro, P, Lee, D S, Krauter, J, Cornillet-Lefebvre, P, Te Kronnie, G, Schäfer, B W, Kubetzko, S, Alonso, C N, zur Stadt, U, Sutton, R, Venn, N C, Izraeli, S, Trakhtenbrot, L, Madsen, H O, Archer, P, Hancock, J, Cerveira, N, Teixeira, M R, Lo Nigro, L, Möricke, A, Stanulla, M, Schrappe, M, Sedék, L, Szczepański, T, Zwaan, C M, Coenen, E A, van den Heuvel-Eibrink, M M, Strehl, S, Dworzak, M, Panzer-Grümayer, R, Dingermann, T, Klingebiel, T, and Marschalek, R

Published
2013
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44. LMO2-associated clonal T cell proliferation in two patients after gene therapy for SCID-X1

Author

Hacein-Bey-Abina, S., Von Kalle, C., Schmidt, M., McCormack, M.P., Wulffraat, N., Leboulch, P., Lim, A., Osborne, C.S., Pawliuk, R., Morillon, E., Sorensen, R., Forster, A., Fraser, P., Cohen, J.I., de Saint Basile, G., Alexander, I., Wintergerst, U., Frebourg, T., Aurias, A., Stoppa-Lyonnet, D., Romana, S., Radford-Weiss, I., Gross, F., Valensi, F., Delabesse, E., Macintyre, E., Sigaux, F., Soulier, J., Leiva, L.E., Wissler, M., Prinz, C., Rabbitts, T.H., Le Deist, F., Fischer, A., and Cavazzana-Calvo, M.

Subjects
Physiological aspects, Complications and side effects, Research, Gene therapy -- Research -- Physiological aspects, Retroviruses -- Research -- Physiological aspects
Abstract

Ex vivo retrovirus-mediated gene transfer into hematopoietic progenitor cells has been shown to be an efficient strategy to correct inherited diseases of the lymphohematopoietic system, provided that a strong selective [...], We have previously shown correction of X-linked severe combined immunodeficiency [SCID-X1, also known as γ chain (γc) deficiency] in 9 out of 10 patients by retrovirus-mediated γc gene transfer into autologous CD34 bone marrow cells. However, almost 3 years after gene therapy, uncontrolled exponential clonal proliferation of mature T cells (with γδ+ or αβ+ T cell receptors) has occurred in the two youngest patients. Both patients' clones showed retrovirus vector integration in proximity to the LMO2 proto-oncogene promoter, leading to aberrant transcription and expression of LMO2. Thus, retrovirus vector insertion can trigger deregulated premalignant cell proliferation with unexpected frequency, most likely driven by retrovirus enhancer activity on the LMO2 gene promoter.

Published
2003

45. Refractory coeliac sprue is a diffuse gastrointestinal disease. (Coeliac Disease)

Author

Verkarre, V., Asnafi, V., Lecomte, T., Mariaud-de Serre, N. Patey, Leborgne, M., Grosdidier, E., Bihan, C. Le, Macintyre, E., Cellier, C., Cerf-Bensussan, N., and Brousse, N.

Subjects
Celiac disease -- Research, T cell lymphoma -- Research, Health
Abstract

Background: Refractory coeliac sprue (RCS) with an immunophenotypically aberrant clonal intra epithelial lymphocyte (IEL) population is considered a cryptic form of intestinal T cell lymphoma. Aims: To investigate the distribution [...]

Published
2003

46. EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations

Author

Langerak, A W, Groenen, P JTA, Brüggemann, M, Beldjord, K, Bellan, C, Bonello, L, Boone, E, Carter, G I, Catherwood, M, Davi, F, Delfau-Larue, M-H, Diss, T, Evans, P AS, Gameiro, P, Sanz, Garcia R, Gonzalez, D, Grand, D, Håkansson, Å, Hummel, M, Liu, H, Lombardia, L, Macintyre, E A, Milner, B J, Montes-Moreno, S, Schuuring, E, Spaargaren, M, Hodges, E, and van Dongen, J JM

Published
2012
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47. EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes

Author

van Dongen, J JM, Lhermitte, L, Böttcher, S, Almeida, J, van der Velden, V HJ, Flores-Montero, J, Rawstron, A, Asnafi, V, Lécrevisse, Q, Lucio, P, Mejstrikova, E, Szczepański, T, Kalina, T, de Tute, R, Brüggemann, M, Sedek, L, Cullen, M, Langerak, A W, Mendonça, A, Macintyre, E, Martin-Ayuso, M, Hrusak, O, Vidriales, M B, and Orfao, A

Published
2012
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