Cervical Intra-epithelial Neoplasia Grade 1 or Worse
Conditions
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.
Interventions
Patients will perform HPV testing themselves at home.
Sponsors
Study design
Eligibility
Inclusion criteria
* attending colposcopy clinic * biopsy-proven CIN1+ lesion * understands study procedures and accepts voluntarily to participate by signing the informed consent form
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with CIN | 12 months | Number of patients with CIN after LEEP. |
Countries
Switzerland