Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial

The “TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia” (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (...

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Autores principales: Koeneman, M. M., Kruse, A. J., Kooreman, L. F. S., zur Hausen, A., Hopman, A. H. N., Sep, S. J. S., Van Gorp, T., Slangen, B. F. M., van Beekhuizen, H. J., van de Sande, A. J. M., Gerestein, C. G., Nijman, H. W., Kruitwagen, R. F. P. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Correspondence
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297094/
https://www.ncbi.nlm.nih.gov/pubmed/28173776
http://dx.doi.org/10.1186/s12885-017-3108-9
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author Koeneman, M. M.
Kruse, A. J.
Kooreman, L. F. S.
zur Hausen, A.
Hopman, A. H. N.
Sep, S. J. S.
Van Gorp, T.
Slangen, B. F. M.
van Beekhuizen, H. J.
van de Sande, A. J. M.
Gerestein, C. G.
Nijman, H. W.
Kruitwagen, R. F. P. M.
author_facet Koeneman, M. M.
Kruse, A. J.
Kooreman, L. F. S.
zur Hausen, A.
Hopman, A. H. N.
Sep, S. J. S.
Van Gorp, T.
Slangen, B. F. M.
van Beekhuizen, H. J.
van de Sande, A. J. M.
Gerestein, C. G.
Nijman, H. W.
Kruitwagen, R. F. P. M.
author_sort Koeneman, M. M.
collection PubMed
description The “TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia” (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the ‘TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3’ study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016.
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spelling pubmed-52970942017-02-10 Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial Koeneman, M. M. Kruse, A. J. Kooreman, L. F. S. zur Hausen, A. Hopman, A. H. N. Sep, S. J. S. Van Gorp, T. Slangen, B. F. M. van Beekhuizen, H. J. van de Sande, A. J. M. Gerestein, C. G. Nijman, H. W. Kruitwagen, R. F. P. M. BMC Cancer Correspondence The “TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia” (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the ‘TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3’ study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016. BioMed Central 2017-02-07 /pmc/articles/PMC5297094/ /pubmed/28173776 http://dx.doi.org/10.1186/s12885-017-3108-9 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Correspondence
Koeneman, M. M.
Kruse, A. J.
Kooreman, L. F. S.
zur Hausen, A.
Hopman, A. H. N.
Sep, S. J. S.
Van Gorp, T.
Slangen, B. F. M.
van Beekhuizen, H. J.
van de Sande, A. J. M.
Gerestein, C. G.
Nijman, H. W.
Kruitwagen, R. F. P. M.
Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title_full Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title_fullStr Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title_full_unstemmed Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title_short Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
title_sort preliminary stop of the topical imiquimod treatment of high-grade cervical intraepithelial neoplasia (topic) trial
topic Correspondence
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297094/
https://www.ncbi.nlm.nih.gov/pubmed/28173776
http://dx.doi.org/10.1186/s12885-017-3108-9
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