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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Urine sample, 1st stream

    Other intervention

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

  • Cervico-vaginal swab

    Other intervention

    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).

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Primary screening for UCCOther 2 interventions

Trial outcomes

Primary outcomes

1

specificity

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).

Time frame
Month : 12
2

Sensitivity

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).

Time frame
Month : 12

Secondary outcomes

1

HPV genotype concordance

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

Time frame
Month : 12
2

Women with a positive evaluation

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

Time frame
Month : 12

Other outcomes

Sponsors and contacts

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