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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Cervical Intra-epithelial Neoplasia Grade 1 or Worse

Treatments

Device: HPV self-testing

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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.

Enrollment

127 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

127 participants in 1 patient group

HPV self-testing
Experimental group
Description:
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.
Treatment:
Device: HPV self-testing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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