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

CompletedOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

March 8, 2021

Primary Completion Date

July 14, 2021

Study Completion Date

July 31, 2021

Conditions
Cervical Intraepithelial Neoplasia Grade 2/3Carcinoma Cervix
Interventions
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

Trial Locations (2)

20141

IEO European Institute of Oncology, Milan

07100

Coordinamento Consultori Familiari ASSL Sassari, Sassari

Sponsors
All Listed Sponsors
collaborator

Becton, Dickinson and Company

INDUSTRY

collaborator

COPAN ITALIA SPA

UNKNOWN

collaborator

Sciensano

OTHER_GOV

collaborator

Istituto Europeo di Oncologia

OTHER

collaborator

Università degli Studi di Sassari

OTHER

collaborator

ATS Sardegna

UNKNOWN

lead

University of Milano Bicocca

OTHER