Clinical Validation of Molecular Triage in HR-HPV Positive Women

Cervical Carcinoma Clinical Trial

— VALTRIHP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05193669
• Other study ID #: WP7-HPVONC
• Status: Active, not recruiting
• Start date: April 14, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Hiantis Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23941
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Carcinoma

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO	Torino

Sponsors (4)

Lead Sponsor	Collaborator
Hiantis Srl	European Commission, Sciensano, University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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