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| Name | Class |
|---|---|
| European Commission | OTHER |
| Sciensano | OTHER_GOV |
| University of Milano Bicocca | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the index triage test: Pap-test | 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) | Baseline |
| Sensitivity of the index and comparator triage test: HPV molecular test | 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). | Baseline |
| Specificity of the index and comparator triage test | Specificity of the index and comparator triage test(s) performed at the time of reflex testing for \ | Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Armaroli, MD | AOU Città della Salute e della Scienza di Torino, Itay | Principal Investigator |
| Marc Arbyn, MD | Sciensano - Brussels, Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO | Torino | 10123 | Italy |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Cervical swab, cervical biopsies
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |