Clinical Validation of Molecular Triage in HR-HPV Positive Women

NCT05193669 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 23941

Last updated 2023-02-08

No results posted yet for this 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.

Conditions

  • Cervical Carcinoma

Sponsors & Collaborators

  • European Commission

    collaborator OTHER
  • Sciensano

    collaborator OTHER_GOV
  • University of Milano Bicocca

    collaborator OTHER
  • Hiantis Srl

    lead INDUSTRY

Principal Investigators

  • Paola Armaroli, MD · AOU Città della Salute e della Scienza di Torino, Itay

  • Marc Arbyn, MD · Sciensano - Brussels, Belgium

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-11-30
Completion
2023-11-30

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05193669 on ClinicalTrials.gov