Clinical trial NCT04788849: Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples
Official title: Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and First-void Urine Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Carcinoma Cervix
Keywords: Self-Sampling
HPV testing
Diagnostic Test Accuarcy
Cervical Cancer Screening
Cervical Intraepithelial Neoplasia
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
name: COPAN ITALIA SPA
name: Sciensano
name: Istituto Europeo di Oncologia
name: Università degli Studi di Sassari
name: ATS Sardegna
First posted: 2021-03-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a recent history of abnormal Pap smear who are referred to colposcopy in one of the 2 Italian Colposcopy Centres:

* Istituto Europeo di Oncolgia (IEO), Milan
* Coordinamento Consultori Familiari, ATS Sardegna

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analytical performance and Clinical accuracy
timeFrame: 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 outcomes:
measure: Women's Acceptance and Preferences regarding urine collection, vaginal self-sampling or cervical sample collection by a clinician.
timeFrame: One day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO European Institute of Oncology
city: Sassari
country: Italy
facility: Coordinamento Consultori Familiari ASSL Sassari
Study officials:
affiliation: School of Medicine and Surgery, University of Milano-Bicocca
name: Clementina E. Cocuzza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.