Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).

NCT06254846 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Phase

Not applicable

Started

2024-05-23

Last updated

2026-05-06

Condition(s) studied

Uterine Cervical Cancer

Investigational drug(s) / intervention(s)

Urine sample, 1st streamCervico-vaginal swab

Urine sample, 1st stream: Use of the Colli-Pee® device for collecting the first urine stream

Cervico-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).

Study 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

FEMALE

Min age

30 Years

Max age

65 Years

Healthy volunteers

Accepted

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: \-

Primary outcome measure(s)

specificity — Month : 12
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).
Sensitivity — Month : 12
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).

Trial sites (1)

Facility	City	Region	Status
Service de Gynécologie Obstétrique - CHU Saint-Etienne	Saint-Etienne	France	Recruiting

More Centre Hospitalier Universitaire de Saint Etienne trials in France

Synergy Between Physical Activity and Outdoor Green Environments to Reduce the Intensity of Negative Symptoms in Schizophrenia. Recruiting

Impact of Fatty Stimuli on Cerebral Activity in Anorexia Nervosa: a Multi-sensory Approach Starting soon

Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses Active, not recruiting

Biomarkers Impact Evaluation on the Post-transplant Immune Response After Allografting of Hematopoietic Stem Cells Recruiting

Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06254846 on ClinicalTrials.gov ↗ ← All trials in France