CIN2-3 premalignant lesion of the cervix
Conditions
Interventions
Patients are allocated to one of two treatment groups according to their
preference:
1. Imiquimod treatment. Patients in this group are treated by a 16-week regime
of imiquimod 5% cream. A control
Cervical intraepithelial neoplasia
Imiquimod
Treatment
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy - age of 18 years or older
Exclusion criteria
Exclusion criteria: - previous histologically confirmed high-grade CIN (CIN 2*3) - PAP 4 cytology as indication for the current baseline colposcopy - concomitant vulvar and/or vaginal intraepithelial neoplasia - previous cervical malignancy - current malignant disease - immunodeficiency (including HIV/AIDS and immunodepressive medication) - pregnancy or lactation - legal incapability - insufficient knowledge of the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations. Treatment efficacy for the imiquimod group is defined as regression to CIN 1 or less at 20 weeks follow-up. Treatment efficacy for the standard treatment group is defined as no need for additional treatment within 6 months after LLETZ treatment. 2. Identification of predictive biomarkers for treatment efficacy of imiquimod in the individual patient, based on biomarkers reflecting host, virus and cellular factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the incidence and severity of side effects of imiquimod therapy, compared to LLETZ treatment. - To assess histological disease recurrence within 24 months follow-up, for both treatment groups. - To assess Quality of life (QoL) before, during and after treatment for both treatment groups. | — |
Countries
The Netherlands
Outcome results
None listed