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

• Conditions: Cervical Intraepithelial Neoplasia Grade 2/3; Carcinoma Cervix
• Interventions: Diagnostic Test: BD Onclarity™ HPV assay

• Registration Number: NCT04788849
• Lead Sponsor: University of Milano Bicocca

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.

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-06
• Study Start: 2021-03-08
• Study First Posted: 2021-03-09
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women referred to colposcopy	BD Onclarity™ HPV assay	Three sample types (urine, vaginal and cervical) will be collected from all enrolled women.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Coordinamento Consultori Familiari ASSL Sassari; 🇮🇹 Sassari, Italy

IEO European Institute of Oncology; 🇮🇹 Milan, Italy