NCT03064087

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Marc Arbyn · Other Government
• Sex: Female
• Age: 25 Years – 64 Years
• Healthy volunteers: —

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.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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).
DEVICE	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)
DEVICE	Qvintip	or with Qvintip (Aprovix AB, Uppsala, Sweden).
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2017-12-29
• Primary completion: 2024-12-31
• Completion: 2027-11-17
• First posted: 2017-02-24
• Last updated: 2023-03-29

Locations

5 sites across 1 country: Belgium

Regulatory

• FDA-regulated device study