Brief Title
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
Official Title
European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples
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 vaginal and a urine collection device is as accurate to detect cervical pre-cancer
as on cliniciantaken cervical samples.
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 Colli-Pee device) and a vaginal sample (with the FLOQSwab device),
prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also
take a cervical sample (with a Cervex-Brush using the same procedure normally adopted for
cervical cytology and/or HPV testing. During colposcopy, a colposcopy-targeted biopsy may be
taken if appropriate. When according to colposcopy and biopsy results, an excisional
treatment of a cervical precancer lesion is needed, the histology of the excised tissue will
complete the end point of the study. The colposcopy and histological findings will be used as
the gold standard if biopsies are taken.
In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will
provide the study outcome.
Three new PCR-based HPV 'in vitro diagnostic devices' (Papilloplex, HPV Oncopredict RNA, HPV
Oncopredict DNA) developed as part of the SME Instrument Project 'HPV OncoPredict
(GA-806551)' will be assessed.
Study Type
Observational [Patient Registry]
Primary Outcome
Relative accuracy urine vs clinician-collected samples
Secondary Outcome
Absolute accuracy for each sample type
Condition
Cervical Intraepithelial Neoplasia Grade 2/3
Intervention
Self-Collecting Devices
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
600
Start Date
July 16, 2020
Completion Date
March 15, 2022
Primary Completion Date
February 23, 2022
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
Female
Ages
25 Years - 65 Years
Contacts
Marc Arbyn, Dr, ,
Location Countries
Ireland
Location Countries
Ireland
Administrative Informations
NCT ID
NCT04312737
Organization ID
WP6-HPVONC
Secondary IDs
GA-806551
Responsible Party
Sponsor
Study Sponsor
Hiantis Srl
Collaborators
Genefirst LTD
Study Sponsor
Marc Arbyn, Dr, Principal Investigator, Sciensano
Verification Date
January 2023