TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia, a multicenter, open-label, non-randomized, controlled study (TOPIC-3 study)

Completed

• Conditions: CIN2-3; premalignant lesion of the cervix; 10038595

• Registration Number: NL-OMON47108
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-09
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 123

Inclusion Criteria

- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Treatment efficacy of imiquimod 5% cream for the treatment of CIN2-3<br /><br>lesions, compared to LLETZ treatment, in selected populations. Treatment<br /><br>efficacy for the imiquimod group is defined as regression to CIN 1 or less at<br /><br>20 weeks follow-up. Treatment efficacy for the standard treatment group is<br /><br>defined as no need for additional treatment within 6 months after LLETZ<br /><br>treatment.<br /><br>2. Identification of predictive biomarkers for treatment efficacy of imiquimod<br /><br>in the individual patient, based on biomarkers reflecting host, virus and<br /><br>cellular factors.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the incidence and severity of side effects of imiquimod therapy,<br /><br>compared to LLETZ treatment.<br /><br>- To assess histological disease recurrence within 24 months follow-up, for<br /><br>both treatment groups.<br /><br>- To assess Quality of life (QoL) before, during and after treatment for both<br /><br>treatment groups.</p><br>