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

Research output: Contribution to journalLetterAcademicpeer-review

2 Downloads (Pure)

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

Fingerprint

Dive into the research topics of 'Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial'. Together they form a unique fingerprint.

Cite this