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
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Service de Gynécologie Obstétrique - CHU Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Louise MONIOD, MD
louise.moniod@chu-st-etienne.fr
(0)4 77 82 83 83
Backup
Florence RANCON
florence.rancon@chu-st-etienne.fr
(0)4 77 12 08 26
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2027-05
Participants
Target number of participants: 350
Treatments
Other: Primary screening for UCC
Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov