Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
NCT ID: NCT03064087
Last Updated: 2023-03-29
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2017-12-29
2027-11-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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Colli-Pee
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
At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH \& Co. KG, Wiesbaden, Germany).
Evalyn Brush
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
or with Qvintip (Aprovix AB, Uppsala, Sweden).
Abbott RealTime High Risk HPV
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.
Eligibility Criteria
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Inclusion Criteria
* Women between the ages of 25 and 64
Exclusion Criteria
* Women with known pregnancy
* Non-consenting women
* Women that are not able to understand and to sign the informed consent
25 Years
64 Years
FEMALE
No
Sponsors
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Algemeen Medisch Laboratorium
UNKNOWN
Universiteit Antwerpen
OTHER
Regionaal Ziekenhuis Heilig Hart Tienen
OTHER
University Hospital, Antwerp
OTHER
Universitair Ziekenhuis Brussel
OTHER
University Hospital, Ghent
OTHER
Marc Arbyn
OTHER_GOV
Responsible Party
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Marc Arbyn
Coordinator Unit Cancer Epidemiology (Belgian Cancer Centre)
Principal Investigators
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Marc Arbyn, PhD
Role: PRINCIPAL_INVESTIGATOR
Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano
Locations
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UZ Brussels
Brussels, Brussels Capital, Belgium
UZ Ghent
Ghent, East Flanders, Belgium
Heilig Hart Ziekenhuis Tienen
Tienen, Flemish Brabant, Belgium
UZ Antwerp
Antwerp, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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WIV-ISP_2017_001
Identifier Type: -
Identifier Source: org_study_id
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