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

NCT06254846 | Recruiting

• 2 other identifiers: 23CH1372023-A02247-38
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Keywords

HPV; Cervical cancer; Cancer screening

Outcome Measures

Primary Outcomes (2)

• 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).

  Month : 12

• 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).

  Month : 12

Secondary Outcomes (2)

• HPV genotype concordance

  Month : 12

• Women with a positive evaluation

  Month : 12

Study Arms (1)

Primary screening for UCC

OTHER

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

Other: Urine sample, 1st stream; Other: Cervico-vaginal swab

Interventions

Urine sample, 1st stream OTHER

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

Primary screening for UCC

Cervico-vaginal swab 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).

Primary screening for UCC

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Louise MONIOD, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise MONIOD, MD

CONTACT

(0)4 77 82 83 83; louise.moniod@chu-st-etienne.fr

Florence RANCON

CONTACT

(0)4 77 12 08 26; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 12, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)