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

March 28, 2023 updated by: Marc Arbyn

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • UZ Antwerp
      • Liège, Belgium, 4030
        • Centre Hospitalier Universitaire de Liege
    • Brussels Capital Region
      • Brussels, Brussels Capital Region, Belgium, 1000
        • UZ Brussels
    • East Flanders
      • Ghent, East Flanders, Belgium, 9000
        • UZ Ghent
    • Flemish Brabant
      • Tienen, Flemish Brabant, Belgium, 3300
        • Heilig Hart Ziekenhuis Tienen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical accuracy
Time Frame: up to 18 months
• Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples.
up to 18 months
Clinical accuracy
Time Frame: up to 18 months
• Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical accuracy
Time Frame: up to 18 months
• Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples.
up to 18 months
Clinical accuracy
Time Frame: up to 18 months
• 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)
up to 18 months
Clinical accuracy
Time Frame: up to 18 months
• 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
Time Frame: up to 18 months
• 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
Time Frame: up to 18 months
• Positivity rates for beta-globin in the different types of samples.
up to 18 months
Analytical performance
Time Frame: up to 18 months
• 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
Time Frame: up to 18 months
• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Arbyn

Collaborators

University Hospital, Ghent
Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Universiteit Antwerpen
Algemeen Medisch Laboratorium
Regionaal Ziekenhuis Heilig Hart Tienen

Investigators

  • Principal Investigator: Marc Arbyn, PhD, Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2017

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

November 17, 2027

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIV-ISP_2017_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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