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

Overview

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+.

Full Title of Study: “HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with CIN
    • Time Frame: 12 months
    • Number of patients with CIN after LEEP.

Participating in This Clinical Trial

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
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University Hospital, Geneva
    • Provider of Information About this Clinical Study
      • Principal Investigator: Manuela Viviano, Dr – University Hospital, Geneva
    • Overall Contact(s)
      • Manuela Viviano, Jr., 764290187, manuela.viviano@gmail.com

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