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NCT Number: NCT06254846

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

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.

Recruiting

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Chauleur Céline, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Urine sample, 1st stream

Other

Use of the Colli-Pee® device for collecting the first urine stream

Cervico-vaginal swab

Other

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).

Primary outcomes

  1. specificity

    Time frame: 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).

  2. Sensitivity

    Time frame: 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 outcomes

  1. HPV genotype concordance

    Time frame: Month : 12

    Percentage of HPV genotype concordance between first void urine and cervical sample.

  2. Women with a positive evaluation

    Time frame: Month : 12

    Percentage of women with a positive evaluation of the first void urine collection device.

Study contacts

Contact information is provided by the study sponsor or research team.

Florence RANCON

CONTACT

[email protected]

(0)4 77 12 08 26 ext. +33

Louise MONIOD, MD

CONTACT

[email protected]

(0)4 77 82 83 83 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: URAPREV

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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