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

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2027-05-31

Brief 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.

Conditions

Uterine Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Primary screening for UCC

Women aged between 30 and 65 who are candidates for primary screening for UCC will be included.

Group Type: OTHER

Urine sample, 1st stream

Intervention Type: OTHER

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

Cervico-vaginal swab

Intervention Type: 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).

Interventions

Urine sample, 1st stream

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

Intervention Type: 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).

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise MONIOD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Louise MONIOD, MD

Role: CONTACT

louise.moniod@chu-st-etienne.fr

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

Florence RANCON

Role: CONTACT

florence.rancon@chu-st-etienne.fr

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

Other Identifiers

2023-A02247-38

Identifier Type: OTHER

Identifier Source: secondary_id

23CH137

Identifier Type: -

Identifier Source: org_study_id