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+.
Full Title of Study: “HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: May 2018
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.
- Device: HPV self-testing
- Patients will perform HPV testing themselves at home.
Arms, Groups and Cohorts
- Experimental: HPV self-testing
- Patients will perform HPV self-testing at home, prior to their follow-up visit. At the colposcopy visit, the doctor or nurse will also perform HPV testing. This procedure will be repeated at 6 and 12 months following LEEP.
Clinical Trial Outcome Measures
- Number of patients with CIN
- Time Frame: 12 months
- Number of patients with CIN after LEEP.
Participating in This Clinical Trial
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University Hospital, Geneva
- Provider of Information About this Clinical Study
- Principal Investigator: Manuela Viviano, Dr – University Hospital, Geneva
- Overall Contact(s)
- Manuela Viviano, Jr., 764290187, email@example.com
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