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Cervical Intraepithelial Neoplasia Grade 2/3VALHUDESNCT03064087

Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples

An observational study of Cervical Intraepithelial Neoplasia Grade 2/3, run by Marc Arbyn at 5 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 64 years, women only
What is being tested?
Colli-Pee, Multi-Collect Swab and Evalyn Brush
Type of treatment
Medical device
How many people
500 participants
Where
5 sitesBelgium
Study dates
29 Dec 2017to 17 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 64 years
  • Women only
  • Adult

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.

Who may be able to join

  • Women with previous abnormal cervical cancer screening test results
  • Women between the ages of 25 and 64

Who cannot join

  • Hysterectomised women
  • Women with known pregnancy
  • Non-consenting women
  • Women that are not able to understand and to sign the informed consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • UZ Antwerp

    Antwerp, 2000

  • UZ Brussels

    Brussels, Brussels Capital, 1000

  • UZ Ghent

    Ghent, East Flanders, 9000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4030

  • Heilig Hart Ziekenhuis Tienen

    Tienen, Flemish Brabant, 3300

Other trials in Belgium

About this study

Official title: Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-samples and First-void Urine Samples (VALHUDES)

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.

Read the 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.

Being tested
Colli-Pee, Multi-Collect Swab, Evalyn Brush, Qvintip, Abbott RealTime High Risk HPV
Keywords
Self-Sampling, HPV Testing, Diagnostic Test Accuracy, Cervical Intraepithelial Neoplasia, Urine, Cervical Cancer Screening
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colli-PeeDevice

    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 SwabDevice

    At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH \& Co. KG, Wiesbaden, Germany).

  • Evalyn BrushDevice

    Another vaginal self-sample will be collected also at the colposcopy centre either with the Evalyn Brush (Rovers Medical Devices B.V., Oss, Netherlands)

  • QvintipDevice

    or with Qvintip (Aprovix AB, Uppsala, Sweden).

  • Abbott RealTime High Risk HPVDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical accuracy

    • Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples.

    Measured: up to 18 months

  2. Clinical accuracy

    • Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.

    Measured: up to 18 months

Secondary outcomes (7)

  1. Clinical accuracy

    • Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples.

    Measured: up to 18 months

  2. 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)

    Measured: up to 18 months

  3. 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.

    Measured: up to 18 months

  4. 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.

    Measured: up to 18 months

  5. Analytical performance

    • Positivity rates for beta-globin in the different types of samples.

    Measured: up to 18 months

  6. Analytical performance

    • Correlation of cycle number values for HPV16, HPV18, other hrHPV and beta-globin between the different types of samples.

    Measured: up to 18 months

  7. 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]).

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2017
  2. Study start29 Dec 2017
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion17 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03064087
Sponsor's protocol ID
WIV-ISP_2017_001
Acronym
VALHUDES
Status last verified
Mar 2023
First submitted
17 Feb 2017
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24433684

  • 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.

    PubMed 25936581

  • 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.

    PubMed 25713024

  • 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.

    PubMed 26296294

  • 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.

    PubMed 24916950

  • 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.

    PubMed 36049283

  • 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.

    PubMed 36047900

  • 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.

    PubMed 34462004

  • 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.

    PubMed 30195193

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Intraepithelial Neoplasia Grade 2/3, run by Marc Arbyn at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical accuracy (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03064087, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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