Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urine sample, 1st stream, Cervico-vaginal swab.
- Who it may be relevant to
- Registry conditions: Uterine Cervical Cancer. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Urine sample, 1st stream
Use of the Colli-Pee® device for collecting the first urine stream - Other 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).
Primary outcome measures
- specificity [Time frame: Month : 12]
- Sensitivity [Time frame: Month : 12]
Secondary outcome measures (2)
- HPV genotype concordance [Time frame: Month : 12]
- Women with a positive evaluation [Time frame: Month : 12]
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Service de Gynécologie Obstétrique - CHU Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT06254846 · 23CH137 · 2023-A02247-38