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

Cervical Intra-epithelial Neoplasia Grade 1 or Worse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780960
• Other study ID #: 15-285
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2020

Study information

• Verified date: January 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intra-epithelial Neoplasia Grade 1 or Worse
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Device:
• HPV self-testing
Patients will perform HPV testing themselves at home.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Genève

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with CIN	Number of patients with CIN after LEEP.	12 months