HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.

Overview

The HIPPOPROJECT is a randomized healthcare study nested in the OCCSP in Poland. This project will assess the performance of the new screening test (HR HPV test) before its implementation in Poland.

Full Title of Study: “HPV Testing In Polish POpulation-based Cervical Cancer Screening Program – a Randomized Healthcare Policy Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Detailed Description

The study assumes randomized assumption of 33,000 women aged 30-59 to cytology or HR HPV test in a 1:1 ratio with age stratification (three strata: 30-39, 40-49 and 50-59 years). The study will start on September 2019 at the Department of Cervical Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw. To obtain results representative for the entire country several sites are planned for inclusion in the study from 2020 in 10 regions of Poland. Primary end-points include the detection rate of histologically confirmed high grade intraepithelial lesions or worse in each screening arm. Selected secondary endpoints include detection rate ratios, colposcopy referral rates and positive predictive values of referral for colposcopy. Additionally, biobanking of cytological samples taken from patients participating in the HIPPO Project is planned in Maria Sklodowska-Curie National Research Institute of Oncology for the purpose of potential future restrospective analyses if new cervical cancer screening technologies emerge. The study has been approved by a local bioethics committee.

Interventions

  • Diagnostic Test: Offering an alternative cervical cancer screening method – hrHPV molecular testing.
    • Women randomized to this screening strategy group will take a hrHPV molecular test. hrHPV-positive – reflex LBC: Abnormal reflex LBC (ASC-US or worse) -> colposcopy Normal reflex LBC -> repeat LBC in 6 months Positive – colposcopy Negative – rescreen in 3 years HPV-negative – rescreen in 5 years

Arms, Groups and Cohorts

  • No Intervention: Conventional exfoliative cytology/LBC
    • According to current Polish guidelines: ASC-US: repeat Pap testing in 6 months – current standard protocol LSIL – repeat Pap testing in 6 months or refer for colposcopy (by the decision of cytologist) – current standard protocol ASC-H and higher and all glandular lesions – refer for colposcopy – current standard protocol Colposcopy-targeted biopsies will be taken in agreement with national guidelines. If screening cytology is negative -> rescreening after 3 years.
  • Experimental: hrHPV molecular testing
    • hrHPV-positive – reflex LBC: Abnormal reflex LBC (ASC-US or worse) -> colposcopy Normal reflex LBC -> repeat LBC in 6 months Positive – colposcopy Negative -> The CINtec PLUS Cytology and The QIASURE methylation test The CINtec PLUS Cytology Positive -> colposcopy Negative -> rescreen in 3 years The QIASURE methylation test Positive -> colposcopy Negative -> rescreen in 3 years Colposcopy-targeted biopsies will be taken in agreement with national guidelines. HPV-negative – rescreen in 5 years

Clinical Trial Outcome Measures

Primary Measures

  • Detection rate of histologically confirmed CIN2 or worse in each screening arm
    • Time Frame: 12 months after the date of the positive screening test
  • Detection rate ratio of CIN2+ in HPV test vs cytology arm (and detection rate ratios between the hrHPV test and cytology)
    • Time Frame: 12 months after the date of the positive screening test
    • This is defined as: number of women with CIN2+ detected in the HPV arm/women screened by HPV …………………………………………………………………………………………………………… number of women with CIN2+ detected in the cytology arm/women screened in with cytology

Secondary Measures

  • Detection rate ratio of CIN1+, CIN3+ (including adeno-carcinoma-in-situ) and cervical cancer (ITT).
    • Time Frame: 12 months after the date of the positive screening test
  • Detection rate ratios of CIN2+ (and CIN1+, CIN3+, cancer) in the per-protocol analysis, restricted to women who adhered to the foreseen follow-up.
    • Time Frame: 12 months after the date of the positive screening test

Participating in This Clinical Trial

Inclusion Criteria

-women aged 30-59 with no screening Pap test within the preceding three years in the OCCSP and women with risk factors entitled to annual screening based on information from the SIMP and not tested within preceding 12 months (based on information from the screening database SIMP) Exclusion Criteria:

-women with screening Pap test within the preceding three years in the OCCSP

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maria Sklodowska-Curie Institute – Oncology Center
  • Collaborator
    • Ministry of Health, Poland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Andrzej Nowakowski, MD, PhD, +48 603942962, Andrzej.Nowakowski@coi.pl

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