Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-samples and First-void Urine Samples (VALHUDES)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 5
- Primary Endpoint
- Clinical accuracy
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 25 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinical accuracy
Time Frame: up to 18 months
• Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.
Secondary Outcomes
- Clinical accuracy(up to 18 months)
- Analytical performance(up to 18 months)
- Acceptance and preferences(up to 18 months)
Investigators
Marc Arbyn
Coordinator Unit Cancer Epidemiology (Belgian Cancer Centre)
Sciensano