Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia

Completed

• Conditions: Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia

• Registration Number: NCT00931190
• Lead Sponsor: Lund University

Brief Summary

The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Detailed Description

Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Study Timeline

• Study Start: 2001-02
• Study Completion: 2005-11
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 195

Inclusion Criteria

• Referral to Umeå university hospital for treatment due to abnormal Pap smear.

Exclusion Criteria

• Lack of informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Dept. obstetrics and gynecology, University hospital of Northern Sweden; 🇸🇪 Umeå, Sweden