Carcinoma Cervix, Cervical Intraepithelial Neoplasia Grade 2/3
Conditions
Keywords
Self-Sampling, HPV testing, Diagnostic Test Accuarcy, Cervical Cancer Screening, Cervical Intraepithelial Neoplasia
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTBD 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
Sponsors
Becton, Dickinson and Company
COPAN ITALIA SPA
Sciensano
Istituto Europeo di Oncologia
Università degli Studi di Sassari
ATS Sardegna
University of Milano Bicocca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analytical performance and Clinical accuracy | One day, with possible extension if excision biopsy is planned based on the coloposcopy/histology outcome of tissue specimens collected at the enrolment visit. | Concordance of the presence of HPV and of the partial and extended HPV genotyping results applied on self- and clinician-collected samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician. | One day | 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. |
Countries
Italy
Outcome results
None listed