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

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    33000
  • sponsor
    Maria Sklodowska-Curie Institute - Oncology Center
Updated on 15 February 2022
cancer
cancer screening
diagnostic procedures
pap smear
colposcopy
cervical cancer screening
human papilloma virus vaccine
hpv test
screening method

Summary

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.

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.

Details
Condition Cervical Cancer
Treatment Offering an alternative cervical cancer screening method - hrHPV molecular testing.
Clinical Study IdentifierNCT04111835
SponsorMaria Sklodowska-Curie Institute - Oncology Center
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

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
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