Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2021-07-31

Brief Summary

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The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™.

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Detailed Description

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Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with UriSponge™ 8E031S100 device) and a vaginal sample (with FLOQSwab® 5E089N device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also collect a cervical sample using a Cervex-Brush.

A colposcopy-targeted biopsy or histology following excisional treatment of a cervical precancer lesion will be undertaken if appropriate. The colposcopy and/or histological findings will be used as the gold standard. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.

Virological accuracy of HPV testing using: \[a\] BD Onclarity on FLOQSwab® 5E089N vaginal self-samples, \[b\] BD Onclarity on UriSponge™ 8E031S100 urine specimens, will be compared to BD Onclarity testing on a cervical samples collected by a clinician.

Conditions

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Cervical Intraepithelial Neoplasia Grade 2/3 Carcinoma Cervix

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women referred to colposcopy

Three sample types (urine, vaginal and cervical) will be collected from all enrolled women.

BD Onclarity™ HPV assay

Intervention Type DIAGNOSTIC_TEST

Women will be asked to self-collect first-void urine using Copan's UriSponge™ 8E031S100 and vaginal swabs using Copan's FLOQSwabs® 5E089N. All samples will be tested with BD Onclarity™ HPV assay. HPV test results on self-collected samples will be compared to those obtained when testing clinician-collected cervical sample

Interventions

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BD Onclarity™ HPV assay

Women will be asked to self-collect first-void urine using Copan's UriSponge™ 8E031S100 and vaginal swabs using Copan's FLOQSwabs® 5E089N. All samples will be tested with BD Onclarity™ HPV assay. HPV test results on self-collected samples will be compared to those obtained when testing clinician-collected cervical sample

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Copan's FLOQSwabs® 5E089N Copan's UriSponge™ 8E031S100

Eligibility Criteria

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Inclusion Criteria

* Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form

Exclusion Criteria

* Women younger than 25 or older than 64 years of age
* Hysterectomized women
* Women with known pregnancy
* Non-consenting women
* Women that are not able to understand and/or sign the informed consent.

Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No