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Trial Title:
Evaluation of First-void Urine as an Alternative to Cervical Sampling for Human Papillomavirus (HPV) Testing in Cervical Cancer Screening (Single-center Study).
NCT ID:
NCT06254846
Condition:
Uterine Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
HPV
Cervical cancer
Cancer screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective, single-centre study to assess the diagnostic performance (sensitivity and
specificity) of HPV PCR on 1st-draft urine compared with cervico-vaginal sampling (= gold
standard).
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Urine sample, 1st stream
Description:
Use of the Colli-Pee® device for collecting the first urine stream
Arm group label:
Primary screening for UCC
Intervention type:
Other
Intervention name:
Cervico-vaginal swab
Description:
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).
Arm group label:
Primary screening for UCC
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.
Criteria for 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:
-
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Address:
City:
Saint-Etienne
Zip:
42055
Country:
France
Status:
Recruiting
Investigator:
Last name:
Chauleur Céline, MD PhD
Email:
Principal Investigator
Start date:
May 23, 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Saint Etienne
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Saint Etienne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254846
