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

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.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3

Interventions

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.

Sponsors & Collaborators

• Algemeen Medisch Laboratorium

  collaborator UNKNOWN

• Universiteit Antwerpen

  collaborator OTHER

• Regionaal Ziekenhuis Heilig Hart Tienen

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Marc Arbyn

  lead OTHER_GOV

Principal Investigators

• Marc Arbyn, PhD · Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano

Eligibility

Min Age

25 Years

Max Age

64 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-29

Primary Completion

2024-12-31

Completion

2027-11-17

FDA Device

Yes

Countries

• Belgium

Study Locations