Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).

Last updated: January 24, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Disorders

Cervical Cancer

Treatment

Urine sample, 1st stream

Cervico-vaginal swab

Clinical Study ID

NCT06254846
23CH137
2023-A02247-38
  • Ages 30-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

Papillomaviruses are responsible for almost all cervical cancers. In France, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. One of the ways to prevent this cancer is screening by PCR on cervical sample for which national coverage rate remains very insufficient (<60%). The invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. In this context, an alternative sample, such as the first-void urine, seems to be judicious. Nevertheless, some studies have shown a lack of sensitivity of the HPV PCR test on urine. As underlined by the French National Authority for Health (HAS), this is mainly due to a lack of standardization of urine collection. In this study, the investigators therefore propose to evaluate the performance of the HPV PCR test on first-void urine using a standardized protocol. Through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age between 30 and 65

  • Consulting in the Gynecology-Obstetrics department for primary cervical cancerscreening

  • Patient affiliated or entitled to a social security regimen

  • Patient who has received information about the study and expressed non-opposition

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Urine sample, 1st stream
Phase:
Study Start date:
May 23, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Service de Gynécologie Obstétrique - CHU Saint-Etienne

    Saint-Etienne, 42055
    France

    Active - Recruiting

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