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

Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial

— Ext-VALHUDES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788849
• Other study ID #: UMilanoBicocca&BD/Copan
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2021
• Source: University of Milano Bicocca
• Contact: Marc Arbyn, MD
• Phone: +3226425021
• Email: marc.arbyn[@]sciensano.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma Cervix
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Italy	IEO European Institute of Oncology	Milan
Italy	Coordinamento Consultori Familiari ASSL Sassari	Sassari

Sponsors (7)

Lead Sponsor	Collaborator
University of Milano Bicocca	ATS Sardegna, Becton, Dickinson and Company, COPAN ITALIA SPA, Istituto Europeo di Oncologia, Sciensano, Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22. — View Citation

Arbyn M, Smith SB, Temin S, Sultana F, Castle P; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ. 2018 Dec 5;363:k4823. doi: 10.1136/bmj.k4823. — View Citation

Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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