Status:
COMPLETED
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
Lead Sponsor:
Hiantis Srl
Collaborating Sponsors:
Genefirst LTD
Sciensano
Conditions:
Cervical Intraepithelial Neoplasia Grade 2/3
Neoplasm Cervix
Eligibility:
FEMALE
25-65 years
Brief Summary
The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vagin...
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 the Co...
Eligibility Criteria
Inclusion
- Women referred to colposcopy evaluation for any reason \[i.e. previous history of abnormal cervical screen test results (cytology, HPV test), previous abnormal colposcopy\]
- Ability to understand and sign the informed consent
- Informed consent given
Exclusion
- Age \< 25 or \> 65 years
- Past history of hysterectomy
- Women with known pregnancy
- Pregnancy within last 3 months
- Vulnerable patient: a patient who is or may be for any reason unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation
- Simultaneous involvement in any other research project
Key Trial Info
Start Date :
July 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04312737
Start Date
July 16 2020
End Date
March 15 2022
Last Update
January 6 2023
Active Locations (6)
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1
The Coombe Women and Infants University Hospital, & Trinity College
Dublin, Ireland
2
Dipartimento di Chirurgia e Medicina - Università Milano-Bicocca
Monza, Monza Brianza, Italy
3
Spedali Civili di Brescia
Brescia, Italy
4
European Institute of Oncology
Milan, Italy