CIN 2/3 high grade cervical intraepithelial neoplasia
Conditions
Interventions
Patients will be randomized into one of two groups:
1. Imiquimod treatment. Patients in this group are treated by a 16-week regime
of imiquimod 5% cream.
2. Standard treatment. LLETZ will be perform
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 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: - immuno-compromised women, - pregnant of lactating women, - legally incapable women - previous histologically confirmed high grade CIN (CIN 2-3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions after imiquimod or conservative management, defined as regression to CIN 1 or less, at 20 weeks follow-up and adequate treatment of high-grade CIN by LLETZ, defined as no need for additional treatment within 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effects of imiquimod therapy and LLETZ therapy as scored by the Common Terminology Criteria for Adverse Events guidelines. 2. Disease recurrence at 6, 12 and 24 months follow-up, defined as abnormal cervical cytology for all treatment roups. 3. Quality of life (QoL) before, during and after treatment, assessed by the following QoL questionnaires at 0 and 20 weeks and after 1 year: a. Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36), to assess generic health-related quality of life b. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-C30, to assess cancer-specific health-related quality of life c. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-CX24, to assess cervical cancer specific quality of life, including sexual functioning | — |
Countries
Netherlands
Outcome results
None listed