Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
- Conditions
- Cervical Intra-epithelial Neoplasia Grade 1 or Worse
- Registration Number
- NCT02780960
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.
- Detailed Description
The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).
Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).
the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 127
- attending colposcopy clinic
- biopsy-proven CIN1+ lesion
- understands study procedures and accepts voluntarily to participate by signing the informed consent form
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of patients with CIN 12 months Number of patients with CIN after LEEP.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Geneva University Hospital
🇨🇭Genève, Switzerland
Geneva University Hospital🇨🇭Genève, Switzerland