Clinical trial NCT03064087: Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
Official title: Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-samples and First-void Urine Samples (VALHUDES)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Keywords: Self-Sampling
HPV Testing
Diagnostic Test Accuracy
Cervical Intraepithelial Neoplasia
Urine
Cervical Cancer Screening
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Algemeen Medisch Laboratorium
name: Universiteit Antwerpen
name: Regionaal Ziekenhuis Heilig Hart Tienen
name: University Hospital, Antwerp
name: Universitair Ziekenhuis Brussel
name: University Hospital, Ghent
First posted: 2017-02-24
Enrollment: 500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical accuracy
timeFrame: up to 18 months
measure: Clinical accuracy
timeFrame: up to 18 months
Secondary outcomes:
measure: Clinical accuracy
timeFrame: up to 18 months
measure: Clinical accuracy
timeFrame: up to 18 months
measure: Clinical accuracy
timeFrame: up to 18 months
measure: Analytical performance
timeFrame: up to 18 months
measure: Analytical performance
timeFrame: up to 18 months
measure: Analytical performance
timeFrame: up to 18 months
measure: Acceptance and preferences
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussels
state: Brussels Capital Region
city: Ghent
country: Belgium
facility: UZ Ghent
state: East Flanders
city: Tienen
country: Belgium
facility: Heilig Hart Ziekenhuis Tienen
state: Flemish Brabant
city: Antwerp
country: Belgium
facility: UZ Antwerp
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
Study officials:
affiliation: Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano
name: Marc Arbyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.