Uterine Cervical Cancer
Conditions
Keywords
HPV, Cervical cancer, Cancer screening
Brief 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.
Interventions
OTHERUrine sample, 1st stream
Use of the Colli-Pee® device for collecting the first urine stream
OTHERCervico-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).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, single-centre study to assess the diagnostic performance (sensitivity and specificity) of HPV PCR on 1st-draft urine compared with cervico-vaginal sampling (= gold standard).
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| specificity | 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). |
| Sensitivity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV genotype concordance | Month : 12 | Percentage of HPV genotype concordance between first void urine and cervical sample. |
| Women with a positive evaluation | Month : 12 | Percentage of women with a positive evaluation of the first void urine collection device. |
Countries
France
Contacts
CONTACTLouise MONIOD, MD
CONTACTFlorence RANCON
PRINCIPAL_INVESTIGATORLouise MONIOD, MD
Centre Hospitalier Universitaire de Saint Etienne
Outcome results
None listed