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

NCT04788849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-07-29

No results posted yet for this 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™.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Carcinoma Cervix

Interventions

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

Sponsors & Collaborators

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • COPAN ITALIA SPA

    collaborator UNKNOWN

  • Sciensano

    collaborator OTHER_GOV

  • Istituto Europeo di Oncologia

    collaborator OTHER

  • Università degli Studi di Sassari

    collaborator OTHER

  • ATS Sardegna

    collaborator UNKNOWN

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Clementina E. Cocuzza, MD, PhD · School of Medicine and Surgery, University of Milano-Bicocca

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-07-14
Completion
2021-07-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788849 on ClinicalTrials.gov