Adjuvant vaccination against HPV in surgical treatment of CIN lesions, a Randomised Controlled Trial.

Phase 4

Recruiting

Conditions: cervical intra-epithelial neoplasia
precursor of cervical cancer
10038594

Registration Number: NL-OMON54737

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

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
<p>Primary outcome<br /><br>Recurrence of CIN II-III after 24 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome<br /><br>1 Recurrence of CIN I-II-III at 6 and 24 months<br /><br>2 The effect of treatments on HPV DNA presence<br /><br>3 Pap-smear results<br /><br>4 Number of LEEP<br /><br>5 Cost-effectiveness analysis<br /><br>6 Quality of life<br /><br>7 Side effects and adverse events</p><br>