Clinical Validation of Molecular Triage in HR-HPV Positive Women

Active, not recruiting

• Conditions: Cervical Carcinoma

• Registration Number: NCT05193669
• Lead Sponsor: Hiantis Srl

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-12-11
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-18
• Primary Completion: 2022-11-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-04
• Last Update Posted: 2023-02-08
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 23941

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

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