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

BMC Cancer. 2017 Feb 7;17(1):110. doi: 10.1186/s12885-017-3108-9.

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.

Publication types

  • Clinical Trial
  • Letter

MeSH terms

  • Administration, Topical
  • Aminoquinolines / administration & dosage*
  • Aminoquinolines / therapeutic use
  • Antineoplastic Agents, Immunological / therapeutic use
  • Female
  • Humans
  • Imiquimod
  • Uterine Cervical Dysplasia / drug therapy*
  • Uterine Cervical Neoplasms / drug therapy*

Substances

  • Aminoquinolines
  • Antineoplastic Agents, Immunological
  • Imiquimod

Associated data

  • ClinicalTrials.gov/NCT02329171
  • ClinicalTrials.gov/NCT02917746