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RECRUITING
NCT06254846
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

Urine sample, 1st stream

Use of the Colli-Pee® device for collecting the first urine stream

OTHER

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