Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 11:34 PM
Study NCT ID:
NCT05193669
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of Molecular Triage in HR-HPV Positive Women
Sponsor:
Hiantis Srl
Organization:
Study Overview
Official Title:
VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
VALTRIHP
Brief Summary:
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: