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HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia (NCT02780960)

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+.
  • Device: HPV self-testing
    Patients will perform HPV testing themselves at home.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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
    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.

    1 locations

    Switzerland (1)
    • Geneva University Hospital
      recruiting
      Genève, Switzerland, 1205
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    30 April, 2016
    Updated:
    23 October, 2017
    Participants:
    168
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