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

Sponsor

Marc Arbyn (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03064087

Collaborator

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

500

Enrollment

Locations

60.1

Anticipated Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia Grade 2/3	Device: Colli-Pee Device: Multi-Collect Swab Device: Evalyn Brush Device: Qvintip Diagnostic Test: Abbott RealTime High Risk HPV

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 Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 29, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Clinical accuracy [up to 18 months]
• Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples.
Clinical accuracy [up to 18 months]
• Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.

Secondary Outcome Measures

Clinical accuracy [up to 18 months]
• Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples.
Clinical accuracy [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)
Clinical accuracy [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.
Analytical performance [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.
Analytical performance [up to 18 months]
• Positivity rates for beta-globin in the different types of samples.
Analytical performance [up to 18 months]
• Correlation of cycle number values for HPV16, HPV18, other hrHPV and beta-globin between the different types of samples.
Acceptance and preferences [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]).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 64 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussels	Brussels	Brussels Capital Region	Belgium	1000
2	UZ Ghent	Ghent	East Flanders	Belgium	9000
3	Heilig Hart Ziekenhuis Tienen	Tienen	Flemish Brabant	Belgium	3300
4	UZ Antwerp	Antwerp		Belgium	2000
5	Centre Hospitalier Universitaire de Liège	Liège		Belgium	4030