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

Study Overview
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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™.

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.

Official Title
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Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples

Conditions
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Cervical Intraepithelial Neoplasia Grade 2/3, Carcinoma Cervix

Intervention / Treatment
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* Diagnostic Test: BD Onclarity™ HPV assay


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women referred to colposcopy<br>Three sample types (urine, vaginal and cervical) will be collected from all enrolled women. | Diagnostic Test: BD Onclarity™ HPV assay<br>* 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<br>* Other names: Copan's UriSponge™ 8E031S100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analytical performance and Clinical accuracy | Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples. | One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician. | Acceptance and preferences regarding urine collection, vaginal self-sampling or clinicians' collected cervical samples will be assessed through a questionnaire administered to participating women at the time of colposcopy. The questionnaire will allow to determine the percentage of women expressing a preference for urine collection and/or vaginal self-sampling over clinicians' collected cervical samples. | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Sampling, HPV testing, Diagnostic Test Accuarcy, Cervical Cancer Screening, Cervical Intraepithelial Neoplasia