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

NCT04788849 | Completed FDA Device

• 1 other identifier: UMilanoBicocca&BD/Copan
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Self-Sampling; HPV testing; Diagnostic Test Accuarcy; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• Analytical performance and Clinical accuracy

  Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples.

  One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.

Secondary Outcomes (1)

• Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.

  One day

Study Arms (1)

Women referred to colposcopy

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

Diagnostic Test: BD Onclarity™ HPV assay

Interventions

BD Onclarity™ HPV assay DIAGNOSTIC_TEST

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

Also known as: Copan's FLOQSwabs® 5E089N, Copan's UriSponge™ 8E031S100

Women referred to colposcopy

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with a recent history of abnormal Pap smear who are referred to colposcopy in one of the 2 Italian Colposcopy Centres: * Istituto Europeo di Oncolgia (IEO), Milan * Coordinamento Consultori Familiari, ATS Sardegna

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Becton, Dickinson and Company: collaborator
• COPAN ITALIA SPA: collaborator
• Sciensano: collaborator
• Istituto Europeo di Oncologia: collaborator
• Università degli Studi di Sassari: collaborator
• ATS Sardegna: collaborator

Study Sites (2)

IEO European Institute of Oncology

Milan, 20141, Italy

Location

Coordinamento Consultori Familiari ASSL Sassari

Sassari, 07100, Italy

Location

Related Publications (3)

• Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.

  PMID: 30195193 BACKGROUND

• Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.

  PMID: 24433684 BACKGROUND

• Arbyn M, Smith SB, Temin S, Sultana F, Castle P; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ. 2018 Dec 5;363:k4823. doi: 10.1136/bmj.k4823.

  PMID: 30518635 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal, urine and cervical samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

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; Precancerous Conditions

Study Officials

• Clementina E. Cocuzza, MD, PhD

  School of Medicine and Surgery, University of Milano-Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: March 8, 2021
• Primary Completion: July 14, 2021
• Study Completion: July 31, 2021
• Last Updated: July 29, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)