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Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
Sponsor: Marc Arbyn
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.
Official title: Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-samples and First-void Urine Samples (VALHUDES)
Key Details
Gender
FEMALE
Age Range
25 Years - 64 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2017-12-29
Completion Date
2027-11-17
Last Updated
2023-03-29
Healthy Volunteers
Not specified
Interventions
Colli-Pee
First, two first-void urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium) at home, the day before a visit to the colposcopy centre at a gynecology clinic.
Multi-Collect Swab
At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH \& Co. KG, Wiesbaden, Germany).
Evalyn Brush
Another vaginal self-sample will be collected also at the colposcopy centre either with the Evalyn Brush (Rovers Medical Devices B.V., Oss, Netherlands)
Qvintip
or with Qvintip (Aprovix AB, Uppsala, Sweden).
Abbott RealTime High Risk HPV
The hrHPV assay used, will be the Abbott PCR (Abbott GmbH \& Co. KG, Wiesbaden, Germany), which detects separately DNA of HPV16 and HPV18, as well as the pool of twelve other hrHPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The accuracy of this PCR assay for the detection of CIN2+ will be determined on all samples: on the first urine sample and on the vaginal and cervical samples. Furthermore, it is possible that in the future other assays will be validated.
Locations (5)
UZ Brussels
Brussels, Brussels Capital, 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