Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial.
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.
Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Post box 5800, 6202 AZ, Maastricht, The Netherlands. margot.koeneman@mumc.nl.|GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands. margot.koeneman@mumc.nl.
M M
MM
Koeneman
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.
A J
AJ
Kruse
Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.
L F S
LF
Kooreman
Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.
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A
Zur Hausen
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.
A H N
AH
Hopman
Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands.
S J S
SJ
Sep
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.
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T
Van Gorp
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.
B F M
BF
Slangen
Department of Obstetrics and Gynaecology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
H J
HJ
van Beekhuizen
Department of Obstetrics and Gynaecology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
A J M
AJ
van de Sande
Department of Obstetrics and Gynaecology, Meander Medical Center, Amersfoort, The Netherlands.
C G
CG
Gerestein
Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, The Netherlands.
H W
HW
Nijman
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.
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Kruitwagen
D000287:Administration, Topical; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000627:therapeutic use; D000074322:Antineoplastic Agents, Immunological / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077271:Imiquimod; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D002578:Uterine Cervical Dysplasia / Q000188:drug therapy*
D000634:Aminoquinolines; D000074322:Antineoplastic Agents, Immunological; D000077271:Imiquimod
Biological markers; Cervical intraepithelial neoplasia; Human papillomavirus; Imiquimod; Natural history