NCT06254846 Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
| NCT ID | NCT06254846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Uterine Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2024-05-23 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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: \-
Contact & Investigator
Louise MONIOD, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT06254846 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 65 Years, studying Uterine Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06254846 currently recruiting?
Yes, NCT06254846 is actively recruiting participants. Contact the research team at louise.moniod@chu-st-etienne.fr for enrollment information.
Where is the NCT06254846 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06254846 clinical trial?
NCT06254846 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Louise MONIOD, MD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 350 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.