Clinical Validation of Molecular Triage in HR-HPV Positive Women

NCT05193669 | Unknown

• 1 other identifier: WP7-HPVONC
• Study Type: observational
• Target: 23,941
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Carcinoma

Keywords

molecular HPV test; Pap-test; Triage

Outcome Measures

Primary Outcomes (3)

• 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 \<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).

  Month 12

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.

You may qualify if:

• women participating in a cervical cancer screening program using an HPV assay as primary screening test
• positivity to hrHPV;
• written informed consent given.

You may not qualify if:

• total hysterectomy;
• diagnosis of CIN2+ in the last two years;
• hrHPV negative or inadequate.

Sponsors & Collaborators

• Hiantis Srl: lead
• European Commission: collaborator
• Sciensano: collaborator
• University of Milano Bicocca: collaborator

Study Sites (1)

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

Torino, 10123, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical swab, cervical biopsies

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Paola Armaroli, MD

  AOU Città della Salute e della Scienza di Torino, Itay

  PRINCIPAL INVESTIGATOR

• Marc Arbyn, MD

  Sciensano - Brussels, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: January 18, 2022
• Study Start: April 14, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IT (1)