Clinical trial · Observational
Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-samples and First-void Urine Samples (VALHUDES)
NCT03064087CI-TRIAL-00065128VALHUDESactive not recruitingClinicalTrials.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 VALHUDES study is a Diagnostic Test Accuracy study that aims to document the clinical accuracy of hrHPV testing on urine samples, collected under standardised and optimised conditions, and on two types of vaginal self-samples and compare results with those from matching samples taken by a clinician.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abbott RealTime High Risk HPV | Diagnostic Test | — | UNRESOLVED |
| Colli-Pee | Device | — | UNRESOLVED |
| Evalyn Brush | Device | — | UNRESOLVED |
| Multi-Collect Swab | Device | — | UNRESOLVED |
| Qvintip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Clinical accuracy
- timeFrame
- up to 18 months
- description
- • Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples.
- measure
- Clinical accuracy
- timeFrame
- up to 18 months
- description
- • Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.
Secondary outcomes (7)
- measure
- Clinical accuracy
- timeFrame
- up to 18 months
- description
- • Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Women with previous abnormal cervical cancer screening test results * Women between the ages of 25 and 64 Exclusion Criteria: * Hysterectomised women * Women with known pregnancy * Non-consenting women * Women that are not able to understand and to sign the informed consent
References
Publications (9)
- 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, Snijders PJ, Meijer CJ, Berkhof J, Cuschieri K, Kocjan BJ, Poljak M. Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening? Clin Microbiol Infect. 2015 Sep;21(9):817-26. doi: 10.1016/j.cmi.2015.04.015. Epub 2015 May 1. PMID 25936581
- BACKGROUNDArbyn M, Castle PE. Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program. Cancer Epidemiol Biomarkers Prev. 2015 May;24(5):769-72. doi: 10.1158/1055-9965.EPI-14-1417. Epub 2015 Feb 24. PMID 25713024
- BACKGROUNDVerdoodt F, Jentschke M, Hillemanns P, Racey CS, Snijders PJ, Arbyn M. Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer. 2015 Nov;51(16):2375-85. doi: 10.1016/j.ejca.2015.07.006. Epub 2015 Aug 18. PMID 26296294
- BACKGROUNDVorsters A, Van den Bergh J, Micalessi I, Biesmans S, Bogers J, Hens A, De Coster I, Ieven M, Van Damme P. Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):2005-14. doi: 10.1007/s10096-014-2147-2. Epub 2014 Jun 12. PMID 24916950
- DERIVEDVan Keer S, Latsuzbaia A, Vanden Broeck D, De Sutter P, Donders G, Doyen J, Tjalma WAA, Weyers S, Arbyn M, Vorsters A. Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. J Clin Virol. 2022 Oct;155:105271. doi: 10.1016/j.jcv.2022.105271. Epub 2022 Aug 24.