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
- attending colposcopy clinic
- biopsy-proven CIN1+ lesion
- understands study procedures and accepts voluntarily to participate by signing the informed consent form
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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.