Status:
COMPLETED
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Becton, Dickinson and Company
COPAN ITALIA SPA
Conditions:
Cervical Intraepithelial Neoplasia Grade 2/3
Carcinoma Cervix
Eligibility:
FEMALE
25-64 years
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 o...
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 UriSpo...
Eligibility Criteria
Inclusion
- Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form
Exclusion
- 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.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04788849
Start Date
March 8 2021
End Date
July 31 2021
Last Update
July 29 2025
Active Locations (2)
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1
IEO European Institute of Oncology
Milan, Italy, 20141
2
Coordinamento Consultori Familiari ASSL Sassari
Sassari, Italy, 07100