NCT04788849

Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples

Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: Female
• Age: 25 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™.

Detailed description

Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with UriSponge™ 8E031S100 device) and a vaginal sample (with FLOQSwab® 5E089N device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also collect a cervical sample using a Cervex-Brush. A colposcopy-targeted biopsy or histology following excisional treatment of a cervical precancer lesion will be undertaken if appropriate. The colposcopy and/or histological findings will be used as the gold standard. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome. Virological accuracy of HPV testing using: \[a\] BD Onclarity on FLOQSwab® 5E089N vaginal self-samples, \[b\] BD Onclarity on UriSponge™ 8E031S100 urine specimens, will be compared to BD Onclarity testing on a cervical samples collected by a clinician.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3
• Carcinoma Cervix

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BD Onclarity™ HPV assay	Women will be asked to self-collect first-void urine using Copan's UriSponge™ 8E031S100 and vaginal swabs using Copan's FLOQSwabs® 5E089N. All samples will be tested with BD Onclarity™ HPV assay. HPV test results on self-collected samples will be compared to those obtained when testing clinician-collected cervical sample

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-07-14
• Completion: 2021-07-31
• First posted: 2021-03-09
• Last updated: 2025-07-29

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated device study