Clinical Validation of Molecular Triage in HR-HPV Positive Women (VALTRIHP)

Hiantis

Status: Active, not recruiting

Conditions: Cervical Carcinoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05193669

WP7-HPVONC

Details and patient eligibility

About

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.

Enrollment: 23,941 patients

Sex: Female

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women participating in a cervical cancer screening program using an HPV assay as primary screening test
• positivity to hrHPV;
• written informed consent given.

Exclusion criteria

• total hysterectomy;
• diagnosis of CIN2+ in the last two years;
• hrHPV negative or inadequate.