Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

RecruitingOBSERVATIONAL
Enrollment

410

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2026

Conditions
Cervical High Grade Squamous Intraepithelial LesionCervical Intraepithelial Neoplasia Grade 2/3CIN 2/3Cervical Intraepithelial Neoplasia
Interventions
DRUG

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.

DIAGNOSTIC_TEST

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.

OTHER

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.

DIAGNOSTIC_TEST

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.

Trial Locations (15)

Unknown

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

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Stichting Olijf: Dutch patient association for women with gynaecological cancer

UNKNOWN

collaborator

Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology

UNKNOWN

collaborator

Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology

UNKNOWN

collaborator

Erasmus Medisch Centrum: Department of Gynaecology

UNKNOWN

collaborator

Radboud Medisch Centrum: Department of Gynaecology

UNKNOWN

lead

Catharina Ziekenhuis Eindhoven

OTHER