Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, 42055, France
Location status: Recruiting
Location contact
Chauleur Céline, MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06254846
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.
Interested in participating?
Request Info30 year–65 year
Female
Interventional
Not applicable
Saint-Etienne, 42055, France
Location status: Recruiting
Chauleur Céline, MD PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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).
Time frame: Month : 12
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 (%) 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
Percentage of HPV genotype concordance between first void urine and cervical sample.
Time frame: Month : 12
Percentage of women with a positive evaluation of the first void urine collection device.
Contact information is provided by the study sponsor or research team.
Florence RANCON
CONTACT
(0)4 77 12 08 26 ext. +33
Louise MONIOD, MD
CONTACT
(0)4 77 82 83 83 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: URAPREV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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