HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Number of patients with CIN
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: HPV self-testing (Device)
Outcomes
Primary Outcomes
Number of patients with CIN
Time Frame: 12 months
Number of patients with CIN after LEEP.
Secondary Outcomes
No secondary outcomes reported
Investigators
Manuela Viviano
Dr
University Hospital, Geneva