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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05193669

Acronym

VALTRIHP

Enrollment

23941

Registered

2022-01-18

Start date

2021-04-14

Completion date

2023-11-30

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Carcinoma

Keywords

molecular HPV test, Pap-test, Triage

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Italy

Outcome results