Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
Recruiting now · Not applicable
Conditions studied: Uterine Cervical Cancer
In brief
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.
Key facts
- Study ID
- NCT06254846
- Run by
- Centre Hospitalier Universitaire de Saint Etienne
- People needed
- 350
- Starts
- 2024-05-23
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 30 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- Service de Gynécologie Obstétrique - CHU Saint-Etienne — Saint-Etienne, France (enrolling)
Full record on ClinicalTrials.gov
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