Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
FEMALE
Healthy Volunteers
NCT06254846

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

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-05-06

350

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Age between 30 and 65 years
  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

L

Louise MONIOD, MD

CONTACT

F

Florence RANCON

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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