Clinical trial · Observational
Clinical Validation of Molecular Triage in HR-HPV Positive Women
VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
NCT05193669CI-TRIAL-00063738VALTRIHPunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Sensitivity of the index triage test: Pap-test
- timeFrame
- Baseline
- description
- 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)
- measure
- Sensitivity of the index and comparator triage test: HPV molecular test
- timeFrame
- Baseline
- description
- 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).
- measure
- Specificity of the index and comparator triage test
- timeFrame
- Month 12
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * women participating in a cervical cancer screening program using an HPV assay as primary screening test * positivity to hrHPV; * written informed consent given. Exclusion Criteria: * total hysterectomy; * diagnosis of CIN2+ in the last two years; * hrHPV negative or inadequate.
References
Publications (0)
Data not yet available
No reference posted for this study.