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. 2023 Nov 17;23(1):1118.
doi: 10.1186/s12885-023-11597-5.

HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial

Patrycja Glinska  1   2 , Katarzyna Komerska  3 , Beata Janik  3 , Julia Olkowicz  4 , Ilona Jedrzejewska  3 , Anna Macios  3   5 , Paulina Wieszczy  6   7 , Michal F Kaminski  8   3   6   7   9 , Marc Arbyn  10 , Andrzej Nowakowski  3
Affiliations

HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial

Patrycja Glinska et al. BMC Cancer. .

Abstract

Background: An Organised Cervical Cancer Screening Programme (OCCSP) was started in Poland in 2006/2007. Each woman aged 25 to 59 is eligible for a free Pap test every 3 years in OCCSP. Despite implementation of the OCCSP, the age-standardised cervical cancer (CC) incidence and mortality rates in 2019 were 7.3/100 000 and 3.9/100 000 respectively and were still higher than those in Western European countries with well-organised screening programmes. Apart from low coverage of the OCCSP, suboptimal performance of the screening test (conventional cytology) may be partially responsible for this situation. Several countries have already incorporated high risk Human Papillomavirus (hrHPV) testing in CC screening as a more sensitive tool reducing the risk of missing precancerous lesions and allowing for extension of screening intervals. The European Guidelines for Quality Assurance in Cervical Cancer Screening recommend pilot evaluation of a new screening test in country-specific conditions before its implementation.

Methods: The HIPPO project (HPV testing In Polish POpulation-based cervical cancer screening program) is a randomised health services study nested in the OCCSP in Poland. The project will randomise 33 000 women aged 30-59 years to cytology or hrHPV testing (ratio: 1:1) with age stratification. In the cytology arm women with repeated Atypical Squamous Cells of Undetermined Significance (ASC-US) or ≥ Low-Grade Squamous Intraepithelial Lesions (LSIL) are referred for colposcopy. In the other arm, hrHPV ( +) women with ≥ ASC-US reflex Liquid-Based Cytology (LBC) are referred for colposcopy. Primary endpoints include detection rates of histologically confirmed high grade intraepithelial lesions or worse (CIN2 +) in each arm.

Discussion: This pilot randomised healthcare study nested in the OCCSP in Poland will assess and compare the performance of hrHPV testing to current standard-cytology in order to make decisions on implementation of HPV-based screening in the country.

Trial registration: This randomised healthcare service study was prospectively registered at https://clinicaltrials.gov/ (identifier: NCT04111835, protocol ID 28/2019) on 19th of September 2019.

Keywords: Cervical cancer; Cytology; Poland; Screening programme; hrHPV test.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The flowchart of women enrolled in the HIPPO trial. ASC-US—Atypical Squamous Cells of Undetermined Significance. CC – cervical cancer. hrHPV test—high risk Human Papillomavirus test. LBC—Liquid-Based Cytology. LSIL—Low-Grade Squamous Intraepithelial Lesion. NILM—No Intraepithelial Lesion or Malignancy
Fig. 2
Fig. 2
Algorithm of control arm. ASC-US—Atypical Squamous Cells of Undetermined Significance. CC – cervical cancer. hrHPV test—high risk Human Papillomavirus test. LBC—Liquid-Based Cytology. LSIL—Low-Grade Squamous Intraepithelial Lesion. NILM—No Intraepithelial Lesion or Malignancy
Fig. 3
Fig. 3
Algorithm of hrHPV arm. ASC-US—Atypical Squamous Cells of Undetermined Significance. CC – cervical cancer. hrHPV test—high risk Human Papillomavirus test. LBC—Liquid-Based Cytology. LSIL—Low-Grade Squamous Intraepithelial Lesion. NILM—No Intraepithelial Lesion or Malignancy
See this image and copyright information in PMC

References

    1. Solomon D, Davey D, Kurman R, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002;287(16):2114–2119. doi: 10.1001/jama.287.16.2114. - DOI - PubMed
    1. Arbyn M, Anttila A, Jordan J, et al. European Guidelines for quality assurance in cervical cancer screening. 2nd ed. Luxembourg: Office for Official Publications of the European Communities; 2008.
    1. Nowakowski A, Arbyn M, Turkot MH, et al. A roadmap for a comprehensive control of cervical cancer in Poland: integration of available solutions into current practice in primary and secondary prevention. Eur J Cancer Prev. 2020;29(2):157–164. doi: 10.1097/CEJ.0000000000000528. - DOI - PMC - PubMed
    1. Nowakowski A, Wojciechowska U, Wieszczy P, Cybulski M, Kaminski MF, Didkowska J. Trends in cervical cancer incidence and mortality in Poland: is there an impact of the introduction of the organised screening? Eur J Epidemiol. 2017;32(6):529–532. doi: 10.1007/s10654-017-0291-6. - DOI - PubMed
    1. Didkowska J, Wojciechowska U, Olasek P, Caetano dos Santos F, Michalek I. Cancer in Poland 2019. Polish national cancer registry, department of epidemiology and cancer prevention. 2021. Available from: http://www.onkologia.org.pl. Accessed 16 Nov 2023.

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