NCT02780960

Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intra-epithelial Neoplasia Grade 1 or Worse

Interventions

Type	Name	Description
DEVICE	HPV self-testing	Patients will perform HPV testing themselves at home.

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-09-01
• Completion: 2020-10-01
• First posted: 2016-05-24
• Last updated: 2021-02-03

Locations

1 site across 1 country: Switzerland