An observational study in Cervical Intraepithelial Neoplasia Grade 2/3, sponsored by Marc Arbyn. Active, not recruiting at 5 sites in Belgium. Open to female participants aged 25 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Marc Arbyn · Observational
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.
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.
367 studies on the registry are indexed under Uterine Cervical Dysplasia; 70 are open to participants now.
This study's enrollment of 500 is above the median of 435 across 102 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →This is the only study on the registry with Marc Arbyn as lead sponsor.
Counted across the registry records on this site, refreshed daily.
500 women referred to a participating Belgian colposcopy centre (University Hospital of Ghent, Brussels and Antwerp, Hospital of Tienen) because of a previous abnormal cervical cancer screening test result, will be enrolled after obtaining informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH \& Co. KG, Wiesbaden, Germany).
Another vaginal self-sample will be collected also at the colposcopy centre either with the Evalyn Brush (Rovers Medical Devices B.V., Oss, Netherlands)
or with Qvintip (Aprovix AB, Uppsala, Sweden).
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.
Clinical accuracy
• Relative sensitivity and specificity of hrHPV testing on first-void urine vs clinician-collected samples.
Time frame: up to 18 months
Clinical accuracy
• Relative sensitivity and specificity of hrHPV testing on vaginal self-samples vs clinician-collected samples.
Time frame: up to 18 months
Clinical accuracy
• Absolute sensitivity and specificity for finding underlying CIN2+ of hrHPV testing on urine, self- and clinician-collected samples.
Time frame: up to 18 months
Clinical accuracy
• Relative sensitivity and specificity of hrHPV testing on samples taken with the Qvintip vs the Evalyn Brush (non-matched comparison) and on urine samples vs the different vaginal self-samples (matched comparison)
Time frame: up to 18 months
Clinical accuracy
• 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.
Time frame: up to 18 months
Analytical performance
• Concordance of the presence of hrHPV and of the partial HPV genotyping results applied on urine, self- and clinician-collected samples; correlation in viral load (expressed as cycle number values) between samples.
Time frame: up to 18 months
Analytical performance
• Positivity rates for beta-globin in the different types of samples.
Time frame: up to 18 months
Analytical performance
• Correlation of cycle number values for HPV16, HPV18, other hrHPV and beta-globin between the different types of samples.
Time frame: up to 18 months
Acceptance and preferences
• Acceptance of self-sampling, preferences of women (assessed from a questionnaire and from participation rate \[number of women who participate/number of women approached\]).
Time frame: up to 18 months
Plan to share: No
Started Dec 2017 (actual). Primary completion is estimated for Dec 2024, 84 months after the start.
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This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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