Clinical Validation of Molecular Triage in HR-HPV Positive Women

Last updated: February 4, 2023
Sponsor: Hiantis Srl
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Carcinoma

Cervical Cancer

Treatment

N/A

Clinical Study ID

NCT05193669
WP7-HPVONC
  • Ages 25-64
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 23941
Study Start date:
April 14, 2021
Estimated Completion Date:
November 30, 2023

Connect with a study center

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

    Torino, 10123
    Italy

    Site Not Available

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