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

NCT03064087Active, Not RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Marc Arbyn

Enrollment

500

Start Date

2017-12-29

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Colli-PeeMulti-Collect SwabEvalyn BrushQvintipAbbott RealTime High Risk HPV

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3

Eligibility

Age Range

25 Years – 64 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Clinical accuracy

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

Time frame: up to 18 months

Clinical accuracy

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

Time frame: up to 18 months

Secondary Outcomes

Clinical accuracy

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

Time frame: up to 18 months

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)

Time frame: up to 18 months

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.

Time frame: up to 18 months

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.

Time frame: up to 18 months

Analytical performance

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

Time frame: up to 18 months

Analytical performance

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

Time frame: up to 18 months

Acceptance and preferences

• Acceptance of self-sampling, preferences of women (assessed from a questionnaire and from participation rate \[number of women who participate/number of women approached\]).

Time frame: up to 18 months

Locations

UZ Brussels, Brussels, Belgium

UZ Ghent, Ghent, Belgium

Heilig Hart Ziekenhuis Tienen, Tienen, Belgium

UZ Antwerp, Antwerp, Belgium

Centre Hospitalier Universitaire de Liège, Liège, Belgium

Linked Papers

2022-09-01

Clinical Performance of the RealTi m e High Risk HPV Assay on Self-Collected Vaginal Samples within the VALHUDES Framework

Self-samples are becoming a crucial part of HPV-based cervical cancer screening programs to reach nonattendee women and increase screening coverage. Therefore, the VALHUDES framework was established to validate and evaluate HPV tests and devices on self-samples.

2022-08-24

Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study

Urine collection is a non-invasive self-sampling method offering the prospect of reaching women un(der)-screened for cervical cancer. The VALHUDES research framework was designed to address the lack of clinical accuracy data for high-risk (hr)HPV testing using urine samples. Here, we report on the analytical and clinical accuracy of hrHPV testing on first-void urine, collected at home, using an extended HPV genotyping assay. Paired first-void urine (Colli-Pee with UCM, Novosanis; index test) and clinician-collected cervical samples (Cervex-Brush, Rovers in PreservCyt Solution, Hologic; comparator test) were collected from 492 women aged 19 to 72 years attending colposcopy (reference test, with histology if indicated) (VALHUDES; NCT03064087). Extended HPV genotyping was performed on paired samples with the BD Onclarity HPV Assay. Cut-offs defined for cervical samples were also applied for first-void urine. HrHPV testing in first-void urine was similarly sensitive for both CIN2+ (ratio 1.00; 95% CI: 0.93-1.07) and CIN3 (ratio 0.98; 95% CI: 0.88-1.08), and marginally less specific for <CIN2 (ratio 0.92; 95% CI: 0.84-0.996) compared to cervical samples. HPV test agreement between sample pairs expressed as Cohen's Kappa (κ) was moderate to excellent for overall hrHPV and individual genotypes (or groups) (κ=0.56-0.85). BD Onclarity HPV Assay on first-void urine has similar clinical sensitivity and somewhat lower specificity to detect cervical precancer to testing on clinician-collected cervical samples.

Linked Investigators

Marc Arbyn

Severien Van Keer

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