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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Detalles Bibliográficos
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
Descripción
Sumario: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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