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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02247-38 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary screening for UCC | Other | Women aged between 30 and 65 who are candidates for primary screening for UCC will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine sample, 1st stream | Other | Use of the Colli-Pee® device for collecting the first urine stream |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Month : 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HPV genotype concordance | Percentage of HPV genotype concordance between first void urine and cervical sample. | Month : 12 |
| Women with a positive evaluation | Percentage of women with a positive evaluation of the first void urine collection device. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise MONIOD, MD | Contact | (0)4 77 82 83 83 | +33 | louise.moniod@chu-st-etienne.fr |
| Florence RANCON | Contact | (0)4 77 12 08 26 | +33 | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Louise MONIOD, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynécologie Obstétrique - CHU Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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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).
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| Cervico-vaginal swab | Other | 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). |
|
| Month : 12 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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