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

Not Applicable

Completed

• Conditions: Cervical Intra-epithelial Neoplasia Grade 1 or Worse
• Interventions: Device: HPV self-testing

• Registration Number: NCT02780960
• Lead Sponsor: University Hospital, Geneva

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Primary Completion: 2020-09
• Study Completion: 2020-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV self-testing	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with CIN	12 months	Number of patients with CIN after LEEP.

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Genève, Switzerland