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UnknownNCT05193669

Clinical Validation of Molecular Triage in HR-HPV Positive Women

VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus

Status
Unknown
Phase
Study type
Observational
Enrollment
23,941 (actual)
Sponsor
Hiantis Srl · Industry
Sex
Female
Age
25 Years – 64 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2021-04-14
Primary completion
2022-11-30
Completion
2023-11-30
First posted
2022-01-18
Last updated
2023-02-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05193669. Inclusion in this directory is not an endorsement.

Clinical Validation of Molecular Triage in HR-HPV Positive Women (NCT05193669) · Clinical Trials Directory