410
Participants
Start Date
June 1, 2022
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2026
Imiquimod
Imiquimod 5% will be administered in the evening by either a vaginal applicator or administered on a vaginal tampon for three times a week during 16 weeks. Treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies, and at 6 months after completion of imiquimod therapy with cytology and if indicated histology.
3x vaginal swab for microbiome analysis
A vaginal swab will be taken from all patients at inclusion (before start of imiquimod), at colposcopy 20 weeks after start of imiquimod and at 6 months after completion of imiquimod treatment during follow-up appointment.
Expectative management
Expectative management of CIN 2 when preferred by the patient. Follow-up 6 months after baseline colposcopy with cytology and if indicated histology.
2x vaginal swab for microbiome analysis
A vaginal swab will be taken from all patients at inclusion and at 6 months after inclusion during follow-up appointment.
RECRUITING
Amphia, Breda
RECRUITING
Albert Schweitzer Ziekenhuis, Dordrecht
RECRUITING
Catharina Ziekenhuis Eindhoven, Eindhoven
RECRUITING
Tergooi MC, Hilversum
RECRUITING
Medisch Centrum Leeuwarden, Leeuwarden
NOT_YET_RECRUITING
Leiden Universitair Medisch Centrum, Leiden
RECRUITING
Maastricht Universitair Medisch Centrum, Maastricht
RECRUITING
Radboudumc, Nijmegen
RECRUITING
Erasmus Medisch Centrum, Rotterdam
RECRUITING
Franciscus Gasthuis & Vlietland, Rotterdam
RECRUITING
HagaZiekenhuis, The Hague
RECRUITING
Diakonessenhuis, Utrecht
RECRUITING
Máxima MC, Veldhoven
RECRUITING
VieCuri Medisch Centrum, Venlo
RECRUITING
Isala, Zwolle
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Stichting Olijf: Dutch patient association for women with gynaecological cancer
UNKNOWN
Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology
UNKNOWN
Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology
UNKNOWN
Erasmus Medisch Centrum: Department of Gynaecology
UNKNOWN
Radboud Medisch Centrum: Department of Gynaecology
UNKNOWN
Catharina Ziekenhuis Eindhoven
OTHER