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

[摘要] 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.

[发布日期] 2017-02-07

[关键词] Cervical intraepithelial neoplasia;Imiquimod;Biological markers;Human papillomavirus;Natural history