Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254846
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-01-29
Brief Title:
Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus HPV Testing in Cervical Cancer Screening Single-center Study
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus HPV Testing in Cervical Cancer Screening Single-center Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URAPREV
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02247-38 | OTHER | ANSM | None |