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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).
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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.
Key Details
Gender
FEMALE
Age Range
30 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-05-23
Completion Date
2027-05
Last Updated
2025-01-27
Healthy Volunteers
Yes
Conditions
Interventions
Urine sample, 1st stream
Use of the Colli-Pee® device for collecting the first urine stream
Cervico-vaginal swab
Use of a "gold standard" reference method = HPV PCR using the Anyplex® II HPV HR kit (Seegene) carried out on a cervico-vaginal swab in ThinPrep® medium (liquid medium medium into which the cervico-vaginal swab is discharged).
Locations (1)
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, France