Imiquimod treatment of premalignant lesions of the uterine cervix.
Phase 1
- Conditions
- High grade cervical intraepithelial neoplasia.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-001260-34-NL
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 210
Inclusion Criteria
- de novo, CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy,
- 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- immuno-compromised women,
- pregnant or lactating women,
- legally incapable women,
- previous high-grade CIN lesions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions.;Secondary Objective: - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy.<br>- To assess health-related quality of life before, during and after treatment. <br>- To assess the incidence and severity of adverse effects of imiquimod and LLETZ treatment. <br>- To assess long-term recurrence of disease after treatment, by cytological examinations.;Primary end point(s): The endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions after imiquimod or observational management, defined as regression to CIN 1 or less, at 20 weeks.;Timepoint(s) of evaluation of this end point: 20 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy.<br>- Health-related quality of life before, during and after treatment.<br>- incidence and severity of adverse effects of imiquimod and LLETZ treatment.<br>- long-term recurrence of disease after treatment, by cytological examinations;Timepoint(s) of evaluation of this end point: - Biomarker model: baseline.<br>- quality of life: baseline, 20 weeks and one year<br>- adverse effects: 6, 10, 16 and 20 weeks.<br>- recurrence: 6, 12 and 24 months.