Clinical trial · Observational
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples
NCT04788849CI-TRIAL-00092714Ext-VALHUDEScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Cervix | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD Onclarity™ HPV assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women referred to colposcopy
- description
- Three sample types (urine, vaginal and cervical) will be collected from all enrolled women.
- interventionNames
- Diagnostic Test: BD Onclarity™ HPV assay
Primary outcomes (1)
- measure
- Analytical performance and Clinical accuracy
- timeFrame
- One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit.
- description
- Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples.
Secondary outcomes (1)
- measure
- Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form 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.
References
Publications (3)
- BACKGROUNDArbyn 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
- BACKGROUNDArbyn 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
- BACKGROUNDArbyn 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