Status:
UNKNOWN
Clinical Validation of Molecular Triage in HR-HPV Positive Women
Lead Sponsor:
Hiantis Srl
Collaborating Sponsors:
European Commission
Sciensano
Conditions:
Cervical Carcinoma
Eligibility:
FEMALE
25-64 years
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) wi...
Eligibility Criteria
Inclusion
- women participating in a cervical cancer screening program using an HPV assay as primary screening test
- positivity to hrHPV;
- written informed consent given.
Exclusion
- total hysterectomy;
- diagnosis of CIN2+ in the last two years;
- hrHPV negative or inadequate.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
23941 Patients enrolled
Trial Details
Trial ID
NCT05193669
Start Date
April 14 2021
End Date
November 30 2023
Last Update
February 8 2023
Active Locations (1)
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1
AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO
Torino, Italy, 10123