About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Urine sample, 1st stream
Other interventionUse of the Colli-Pee® device for collecting the first urine stream
Cervico-vaginal swab
Other interventionUse 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).
Treatment groups
Trial outcomes
Primary outcomes
specificity
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).
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).
Secondary outcomes
HPV genotype concordance
Percentage of HPV genotype concordance between first void urine and cervical sample.
Women with a positive evaluation
Percentage of women with a positive evaluation of the first void urine collection device.
Sponsors and contacts
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