NCT03064087

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2017Nov 2027

First Submitted

Initial submission to the registry

February 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

December 29, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2027

Expected
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

February 17, 2017

Last Update Submit

March 28, 2023

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Keywords

Self-SamplingHPV TestingDiagnostic Test AccuracyCervical Intraepithelial NeoplasiaUrineCervical Cancer Screening

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • Clinical accuracy

    up to 18 months

  • Clinical accuracy

    up to 18 months

  • Clinical accuracy

    up to 18 months

  • Analytical performance

    up to 18 months

  • Analytical performance

    up to 18 months

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UZ Brussels

Brussels, Brussels Capital, 1000, Belgium

Location

UZ Ghent

Ghent, East Flanders, 9000, Belgium

Location

Heilig Hart Ziekenhuis Tienen

Tienen, Flemish Brabant, 3300, Belgium

Location

UZ Antwerp

Antwerp, 2000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4030, Belgium

Location

Related Publications (9)

  • 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.

    PMID: 24433684BACKGROUND

  • 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.

    PMID: 25936581BACKGROUND

  • 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.

    PMID: 25713024BACKGROUND

  • 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.

    PMID: 26296294BACKGROUND

  • 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.

    PMID: 24916950BACKGROUND

  • 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.

    PMID: 36049283DERIVED

  • 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.

    PMID: 36047900DERIVED

  • 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.

    PMID: 34462004DERIVED

  • 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.

    PMID: 30195193DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Marc Arbyn, PhD

    Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinator Unit Cancer Epidemiology (Belgian Cancer Centre)

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 24, 2017

Study Start

December 29, 2017

Primary Completion

December 31, 2024

Study Completion (Estimated)

November 17, 2027

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)