Clinical Trial: Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
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 Summary:
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.
Sponsor: University Hospital, Geneva
Current Primary Outcome: Number of patients with CIN [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University Hospital, Geneva
Dates:
Date Received: May 13, 2016
Date Started: May 2016
Date Completion: November 2018
Last Updated: August 11, 2016
Last Verified: August 2016