TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): a randomized controlled trial
Phase 3
Completed
- Conditions
- CIN 2/3high grade cervical intraepithelial neoplasia10038595
- Registration Number
- NL-OMON41566
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older
Exclusion Criteria
- immuno-compromised women,
- pregnant of lactating women,
- legally incapable women
- previous histologically confirmed high grade CIN (CIN 2-3)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions<br /><br>after imiquimod or conservative management, defined as regression to CIN 1 or<br /><br>less, at 20 weeks follow-up and adequate treatment of high-grade CIN by LLETZ,<br /><br>defined as no need for additional treatment within 6 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Side effects of imiquimod therapy and LLETZ therapy as scored by the Common<br /><br>Terminology Criteria for Adverse Events guidelines.<br /><br>2. Disease recurrence at 6, 12 and 24 months follow-up, defined as abnormal<br /><br>cervical cytology for all treatment roups.<br /><br>3. Quality of life (QoL) before, during and after treatment, assessed by the<br /><br>following QoL questionnaires at 0 and 20 weeks and after 1 year:<br /><br>a. Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36),<br /><br>to assess generic health-related quality of life<br /><br>b. European Organization for Research and Treatment of Cancer (EORTC)<br /><br>quality-of-life questionnaire: QLQ-C30, to assess cancer-specific<br /><br>health-related quality of life<br /><br>c. European Organization for Research and Treatment of Cancer (EORTC)<br /><br>quality-of-life questionnaire: QLQ-CX24, to assess cervical cancer specific<br /><br>quality of life, including sexual functioning</p><br>