VACCIN study
Recruiting
- Conditions
- Cervical intraepithelial neoplasia (CIN), Human Papilloma Virus (HPV)
- Registration Number
- NL-OMON22561
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 750
Inclusion Criteria
Women 18 years or older
- Histologically proven CIN II or III
- Patients treated with LEEP (inclusion within 4 weeks after LEEP)
Exclusion Criteria
- Prior HPV vaccination
- (Micro-) invasive carcinoma
- Immune-compromised patients
- Pregnancy
- Prior treatment for CIN-lesions
- Insufficient understanding of the Dutch language
- Women allergic to vaccine components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CIN II-III at 24 months
- Secondary Outcome Measures
Name Time Method high risk HPV presence <br>cytology results<br>number of re-interventions<br>cost-effectivity<br>adverse events<br>quality of life