RecruitingNot ApplicableNCT06254846

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

Enrollment

350 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a urine sample collected at home (called first-void urine) can serve as a reliable substitute for a cervical swab taken by a healthcare professional when testing for HPV (human papillomavirus), the main cause of cervical cancer. If shown to work, this could make screening much more accessible. **You may be eligible if...** - You are a woman aged 30–65 - You are visiting a gynecology or obstetrics clinic for routine cervical cancer screening - You are enrolled in a social security system (France-based study) - You have been informed about the study and agree to participate **You may NOT be eligible if...** (No specific exclusion criteria were listed for this study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, France

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NCT06254846


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