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

Not Applicable

Recruiting

• Conditions: Uterine Cervical Cancer
• Interventions: Other: Urine sample, 1st stream; Other: Cervico-vaginal swab

• Registration Number: NCT06254846
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-05-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary screening for UCC	Cervico-vaginal swab	Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.
Primary screening for UCC	Urine sample, 1st stream	Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Women with a positive evaluation	Month : 12	Percentage of women with a positive evaluation of the first void urine collection device.
HPV genotype concordance	Month : 12	Percentage of HPV genotype concordance between first void urine and cervical sample.

Trial Locations

Locations (1)

Service de Gynécologie Obstétrique - CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France