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

Active, not recruiting

• Conditions: Cervical Intraepithelial Neoplasia Grade 2/3

• Registration Number: NCT03064087
• Lead Sponsor: Marc Arbyn

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.

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 Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-12-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12-31
• Study Completion: 2027-11-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical accuracy	up to 18 months	• Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.

Secondary Outcome Measures

Name	Time	Method
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	• 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 \[number of women who participate/number of women approached\]).

Trial Locations

Locations (5)

UZ Brussels; 🇧🇪 Brussels, Brussels Capital Region, Belgium

UZ Ghent; 🇧🇪 Ghent, East Flanders, Belgium

Heilig Hart Ziekenhuis Tienen; 🇧🇪 Tienen, Flemish Brabant, Belgium

UZ Antwerp; 🇧🇪 Antwerp, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium