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

Last updated: July 24, 2025
Sponsor: University of Milano Bicocca
Overall Status: Completed

Phase

N/A

Condition

Cervical Intraepithelial Neoplasia

Neoplasms

Treatment

BD Onclarity™ HPV assay

Clinical Study ID

NCT04788849
UMilanoBicocca&BD/Copan
  • Ages 25-64
  • Female

Study 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™.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: BD Onclarity™ HPV assay
Phase:
Study Start date:
March 08, 2021
Estimated Completion Date:
July 31, 2021

Study 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.

Connect with a study center

  • IEO European Institute of Oncology

    Milan, 20141
    Italy

    Site Not Available

  • Coordinamento Consultori Familiari ASSL Sassari

    Sassari, 07100
    Italy

    Site Not Available

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