Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial
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Publication date
2017-02-07
Authors
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
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Document Type
Letter
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Abstract
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.
Keywords
Biological markers, Cervical intraepithelial neoplasia, Human papillomavirus, Imiquimod, Natural history, Oncology, Genetics, Cancer Research, Letter
Citation
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 2017, 'Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial', BMC Cancer, vol. 17, 17:110. https://doi.org/10.1186/s12885-017-3108-9