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Studies

Observational Active not recruiting

NCT05193669 on ClinicalTrials.gov

Clinical Validation of Molecular Triage in HR-HPV Positive Women

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

  • Sponsor: SRL (Japan)
  • Collaborators: European Commission, Sciensano, University of Milano Bicocca
  • Enrollment: 23941 (Actual)
  • Study start: 2021-04-14 (Actual)
  • Primary completion: 2022-11-30 (Actual)
  • Study completion: 2023-11-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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

Primary Outcome Measures

  • Sensitivity of the index triage test: Pap-test (Baseline)
    Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)
  • Sensitivity of the index and comparator triage test: HPV molecular test (Baseline)
    Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).
  • Specificity of the index and comparator triage test (Month 12)
    Specificity of the index and comparator triage test(s) performed at the time of reflex testing for \<CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for \<CIN2 and relative specificity for \<CIN2 (index vs comparator).

Countries

Italy

Locations and Investigators

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

Study Officials

  • Paola Armaroli, MD (Principal Investigator) — AOU Città della Salute e della Scienza di Torino, Itay
  • Marc Arbyn, MD (Study Director) — Sciensano - Brussels, Belgium