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

University of Milano Bicocca

Status: Completed

Conditions: Carcinoma Cervix; Cervical Intraepithelial Neoplasia Grade 2/3

Treatments: Diagnostic Test: BD Onclarity™ HPV assay

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04788849

UMilanoBicocca&BD/Copan

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form

Exclusion criteria

• Women younger than 25 or older than 64 years of age
• Hysterectomized women
• Women with known pregnancy
• Non-consenting women
• Women that are not able to understand and/or sign the informed consent.

Trial design

300 participants in 1 patient group

Women referred to colposcopy

Description:

Three sample types (urine, vaginal and cervical) will be collected from all enrolled women.

Treatment:

Diagnostic Test: BD Onclarity™ HPV assay