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

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Uterine Cervical Cancer

Treatments

Other: Urine sample, 1st stream

Other: Cervico-vaginal swab

Study type

Interventional

Funder types

Other

Identifiers

NCT06254846

23CH137

2023-A02247-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

Female

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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