Clinical Validation of Molecular Triage in HR-HPV Positive Women

NCT ID: NCT05193669

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 23941 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2023-11-30

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.

Conditions

Cervical Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Sciensano

OTHER_GOV

Sponsor Role: collaborator

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

Hiantis Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Armaroli, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della Salute e della Scienza di Torino, Itay

Marc Arbyn, MD

Role: STUDY_DIRECTOR

Sciensano - Brussels, Belgium

Locations

AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO

Torino, , Italy

Countries

Italy

Other Identifiers

WP7-HPVONC

Identifier Type: -

Identifier Source: org_study_id