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| Name | Class |
|---|---|
| Algemeen Medisch Laboratorium | UNKNOWN |
| Universiteit Antwerpen | OTHER |
| Regionaal Ziekenhuis Heilig Hart Tienen | OTHER |
| University Hospital, Antwerp |
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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.
The samples are collected from patients referred to colposcopy because of prior cervical abnormalities. The patient takes at home two urine samples with the Colli-Pee device (a device that allows to collect first-void urine), the day before the visit to the colposcopy centre. At the colposcopy centre, two vaginal self-samples are taken by the patient herself: one with a cotton swab and a second with a plastic brush. Finally, the gynecologist takes a cervical Pap smear with a Cervex-Brush Combi.
A real-time PCR test will be used to detect DNA of high-risk HPV types. It is possible that in the future also other tests will be validated on these samples. The colposcopy and histological findings will be used as the gold standard. The main purpose of the study is to assess the relative diagnostic tests accuracy of hrHPV testing on self- and urine samples compared to hrHPV testing on cervical samples taken by a clinician. Furthermore, the participating women will receive also a questionnaire which can give insights into the attitudes and preferences of the women with regard to the self-sampling devices.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colli-Pee | Device | First, two first-void urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium) at home, the day before a visit to the colposcopy centre at a gynecology clinic. | ||
| Multi-Collect Swab | Device | At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH & Co. KG, Wiesbaden, Germany). | ||
| Evalyn Brush | Device | Another vaginal self-sample will be collected also at the colposcopy centre either with the Evalyn Brush (Rovers Medical Devices B.V., Oss, Netherlands) | ||
| Qvintip | Device | or with Qvintip (Aprovix AB, Uppsala, Sweden). | ||
| Abbott RealTime High Risk HPV | Diagnostic Test | The hrHPV assay used, will be the Abbott PCR (Abbott GmbH & Co. KG, Wiesbaden, Germany), which detects separately DNA of HPV16 and HPV18, as well as the pool of twelve other hrHPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The accuracy of this PCR assay for the detection of CIN2+ will be determined on all samples: on the first urine sample and on the vaginal and cervical samples. Furthermore, it is possible that in the future other assays will be validated. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical accuracy | • Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples. | up to 18 months |
| Clinical accuracy | • Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical accuracy | • Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples. | up to 18 months |
| Clinical accuracy | • Relative sensitivity and specificity of hrHPV testing on samples taken with the Qvintip vs the Evalyn Brush (non-matched comparison) and on urine samples vs the different vaginal self-samples (matched comparison) |
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Inclusion Criteria:
Exclusion Criteria:
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500 women referred to a participating Belgian colposcopy centre (University Hospital of Ghent, Brussels and Antwerp, Hospital of Tienen) because of a previous abnormal cervical cancer screening test result, will be enrolled after obtaining informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Arbyn, PhD | Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussels | Brussels | Brussels Capital | 1000 | Belgium | ||
| UZ Ghent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24433684 | 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. | |
| 25936581 |
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| OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| University Hospital, Ghent | OTHER |
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First-void urine sample, vaginal self-sample and cervical cell sample collected by a gynecologist. No human DNA is extracted from the samples but the samples can contain HPV DNA.
| up to 18 months |
| Clinical accuracy | • An intermediate statistical analysis will be performed after that 100 patients are included to verify whether all processes run as expected. Possible protocol adjustments may be considered after this intermediate analysis. | up to 18 months |
| Analytical performance | • Concordance of the presence of hrHPV and of the partial HPV genotyping results applied on urine, self- and clinician-collected samples; correlation in viral load (expressed as cycle number values) between samples. | up to 18 months |
| Analytical performance | • Positivity rates for beta-globin in the different types of samples. | up to 18 months |
| Analytical performance | • Correlation of cycle number values for HPV16, HPV18, other hrHPV and beta-globin between the different types of samples. | up to 18 months |
| Acceptance and preferences | • Acceptance of self-sampling, preferences of women (assessed from a questionnaire and from participation rate [number of women who participate/number of women approached]). | up to 18 months |
| Ghent |
| East Flanders |
| 9000 |
| Belgium |
| Heilig Hart Ziekenhuis Tienen | Tienen | Flemish Brabant | 3300 | Belgium |
| UZ Antwerp | Antwerp | 2000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4030 | Belgium |
| Arbyn 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. |
| 25713024 | Background | Arbyn 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. |
| 26296294 | Background | Verdoodt 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. |
| 24916950 | Background | Vorsters 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. |
| 36049283 | Derived | Van 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. |
| 36047900 | Derived | Latsuzbaia A, Vanden Broeck D, Van Keer S, Weyers S, Tjalma WAA, Doyen J, Donders G, De Sutter P, Vorsters A, Peeters E, Arbyn M. Clinical Performance of the RealTime High Risk HPV Assay on Self-Collected Vaginal Samples within the VALHUDES Framework. Microbiol Spectr. 2022 Oct 26;10(5):e0163122. doi: 10.1128/spectrum.01631-22. Epub 2022 Sep 1. |
| 34462004 | Derived | De Pauw H, Donders G, Weyers S, De Sutter P, Doyen J, Tjalma WAA, Vanden Broeck D, Peeters E, Van Keer S, Vorsters A, Arbyn M. Cervical cancer screening using HPV tests on self-samples: attitudes and preferences of women participating in the VALHUDES study. Arch Public Health. 2021 Aug 30;79(1):155. doi: 10.1186/s13690-021-00667-4. |
| 30195193 | Derived | 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. |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| 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 |
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