Viewing Study NCT05193669



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Last Modification Date: 2024-10-26 @ 2:22 PM
Study NCT ID: NCT05193669
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-02-08
First Post: 2021-12-11

Brief Title: Clinical Validation of Molecular Triage in HR-HPV Positive Women
Sponsor: Hiantis Srl
Organization: Hiantis Srl

Study Overview

Official Title: VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-02
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: 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: None
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?: None