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

BMC Cancer

Correspondence

S. J. S. Sep¹  A. J. M. van de Sande²  H. J. van Beekhuizen²  B. F. M. Slangen³  T. Van Gorp³  A. J. Kruse³  R. F. P. M. Kruitwagen³  M. M. Koeneman³  C. G. Gerestein⁴  H. W. Nijman⁵  A. zur Hausen⁶  L. F. S. Kooreman⁶  A. H. N. Hopman⁷ 

[1] Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Obstetrics and Gynaecology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands;Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Post box 5800, 6202 AZ, Maastricht, The Netherlands;GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Obstetrics and Gynaecology, Meander Medical Center, Amersfoort, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, The Netherlands;Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands;GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands;Department of Molecular Cell Biology, Maastricht University Medical Center, Maastricht, The Netherlands;

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

DOI  :  10.1186/s12885-017-3108-9

 received in 2016-11-04, accepted in 2017-02-02,  发布年份 2017

来源: Springer

【 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.

【 授权许可】

CC BY   
© The Author(s). 2017