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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
| COPAN ITALIA SPA | UNKNOWN |
| Sciensano | OTHER_GOV |
| Istituto Europeo di Oncologia |
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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™.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women referred to colposcopy | Three sample types (urine, vaginal and cervical) will be collected from all enrolled women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a recent history of abnormal Pap smear who are referred to colposcopy in one of the 2 Italian Colposcopy Centres:
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| Name | Affiliation | Role |
|---|---|---|
| Clementina E. Cocuzza, MD, PhD | School of Medicine and Surgery, University of Milano-Bicocca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEO European Institute of Oncology | Milan | 20141 | Italy | |||
| Coordinamento Consultori Familiari ASSL Sassari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30195193 | Background | 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. | |
| 24433684 |
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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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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
| Università degli Studi di Sassari | OTHER |
| ATS Sardegna | UNKNOWN |
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Vaginal, urine and cervical samples
|
|
| One day |
| Sassari |
| 07100 |
| Italy |
| 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. |
| 30518635 | 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. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |