Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04312737
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2020-03-11
Brief Title:
Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus
Sponsor:
Hiantis Srl
Organization:
Hiantis Srl
Study Overview
Official Title:
European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EU-VALHUDES
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GA-806551 | OTHER_GRANT | Horizon 2020 SME Instrument Project | None |