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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
350
Use of the Colli-Pee® device for collecting the first urine stream
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).
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, France
RECRUITINGspecificity
specificity (%) of the HPV PCR test on the first void urine (Colli-Pee®) in comparison with the same HPV PCR test applied to the cervical sampling (= gold standard).
Time frame: Month : 12
Sensitivity
Sensitivity (%) of the HPV PCR test on the first void urine (Colli-Pee®) in comparison with the same HPV PCR test applied to the cervical sampling (= gold standard).
Time frame: Month : 12
HPV genotype concordance
Percentage of HPV genotype concordance between first void urine and cervical sample.
Time frame: Month : 12
Women with a positive evaluation
Percentage of women with a positive evaluation of the first void urine collection device.
Time frame: Month : 12
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