Cervical Intraepithelial Neoplasia Grade 2/3Ext-VALHUDESNCT04788849
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Carcinoma Cervix, run by University of Milano Bicocca at 2 sites in Italy.
Trial 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®… Read more about this study
- Who is it for?
- Ages 25 to 64 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3, Carcinoma Cervix
- What is being tested?
- BD Onclarity™ HPV assay
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 8 Mar 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
IEO European Institute of Oncology
Milan, 20141
Coordinamento Consultori Familiari ASSL Sassari
Sassari, 07100
About this study
Official title: Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples
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™.
Read the 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.
- Being tested
- BD Onclarity™ HPV assay
- Keywords
- Self-Sampling, HPV testing, Diagnostic Test Accuarcy, Cervical Cancer Screening, Cervical Intraepithelial Neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Onclarity™ HPV assayDiagnostic test
Also called Copan's FLOQSwabs® 5E089N, Copan's UriSponge™ 8E031S100
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
| Study group | Role | What they receive |
|---|---|---|
| Women referred to colposcopy | Three sample types (urine, vaginal and cervical) will be collected from all enrolled women. Receives: Diagnostic Test: BD Onclarity™ HPV assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Acceptance and preferences regarding urine collection, vaginal self-sampling or clinicians' collected cervical samples will be assessed through a questionnaire administered to participating women at the time of colposcopy. The questionnaire will allow to determine the percentage of women expressing a preference for urine collection and/or vaginal self-sampling over clinicians' collected cervical samples.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start8 Mar 2021
- Primary completion14 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company, COPAN ITALIA SPA, Sciensano, Istituto Europeo di Oncologia, Università degli Studi di Sassari, ATS Sardegna
- Responsible party
- Sponsor
- Investigators
- Clementina E. Cocuzza, MD, PhD, Principal investigator, School of Medicine and Surgery, University of Milano-Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788849
- Sponsor's protocol ID
- UMilanoBicocca&BD/Copan
- Acronym
- Ext-VALHUDES
- Status last verified
- May 2023
- First submitted
- 3 Mar 2021
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study protocol and results have been published: Martinelli M, Latsuzbaia A, Bonde J, Pedersen H, Iacobone AD, Bottari F, Piana AF, Pietri R, Cocuzza CE, Arbyn M; Extended Valhudes Study Group. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiol Spectr. 2024 Mar 5;12(3):e0287223. doi: 10.1128/spectrum.02872-23. Epub 2024 Feb 7. PMID: 38323823; PMCID: PMC10913526.
Publications
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.
PubMed 30195193Arbyn 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.
PubMed 24433684Arbyn 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.
PubMed 30518635
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples
- ClinicalTrials.gov ID
- NCT04788849
- Acronym / sponsor ID
- Ext-VALHUDES / UMilanoBicocca&BD/Copan
- Keywords
- Self-Sampling, HPV testing, Diagnostic Test Accuarcy, Cervical Cancer Screening, Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company, COPAN ITALIA SPA, Sciensano, Istituto Europeo di Oncologia, Università degli Studi di Sassari, ATS Sardegna
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women referred to colposcopy | – | Diagnostic Test: BD Onclarity™ HPV assayThree sample types (urine, vaginal and cervical) will be collected from all enrolled women. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Onclarity™ HPV assayAlso: Copan's FLOQSwabs® 5E089N, Copan's UriSponge™ 8E031S100Women 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 | Diagnostic test | Women referred to colposcopy |
Primary outcome
Analytical performance and Clinical accuracy
Time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples.
1 secondary outcome
Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Background: PubMed 30195193Arbyn 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.
- Background: PubMed 24433684Arbyn 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.
- Background: PubMed 30518635Arbyn 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.
- Individual participant dataSharing planned: No. Study protocol and results have been published: Martinelli M, Latsuzbaia A, Bonde J, Pedersen H, Iacobone AD, Bottari F, Piana AF, Pietri R, Cocuzza CE, Arbyn M; Extended Valhudes Study Group. Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples. Microbiol Spectr. 2024 Mar 5;12(3):e0287223. doi: 10.1128/spectrum.02872-23. Epub 2024 Feb 7. PMID: 38323823; PMCID: PMC10913526.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clementina E. Cocuzza, MD, PhD principal investigator
School of Medicine and Surgery, University of Milano-Bicocca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Carcinoma Cervix, run by University of Milano Bicocca at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analytical performance and Clinical accuracy (time frame: One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.