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

  • M. M. Koeneman*
  • , A. J. Kruse
  • , L. F S Kooreman
  • , A. zur Hausen
  • , A. H N Hopman
  • , S. J S Sep
  • , T. Van Gorp
  • , B. F M Slangen
  • , H. J. van Beekhuizen
  • , A. J M van de Sande
  • , C. G. Gerestein
  • , H. W. Nijman
  • , R. F P M Kruitwagen
  • *Corresponding author for this work

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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.

Original languageEnglish
Article number17:110
JournalBMC Cancer
Volume17
DOIs
Publication statusPublished - 7 Feb 2017

Keywords

  • Biological markers
  • Cervical intraepithelial neoplasia
  • Human papillomavirus
  • Imiquimod
  • Natural history

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