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

RecruitingNAAges 30 Years - 65 YearsFemaleCentre Hospitalier Universitaire de Saint Etienne
NCT06254846 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female * Age between 30 and 65 * Consulting in the Gynecology-Obstetrics department for primary cervical cancer screening * Patient affiliated or entitled to a social security regimen * Patient who has received information about the study and expressed non-opposition Exclusion Criteria: \-
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What it tests

  • Urine sample, 1st stream
  • Cervico-vaginal swab
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Where

1 site
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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