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| ID | Type | Description | Link |
|---|---|---|---|
| 28/2019/1/2020 | Other Identifier | Bioethics Committee of the Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, |
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| Name | Class |
|---|---|
| Ministry of Health, Poland | OTHER_GOV |
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The HIPPO PROJECT 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.
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).
Patients are recruited by the Cervical Cancer Prevention Clinic at the Department of Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw (main centre) and 8 more sites from distant regions of Poland (Lublin, Masovian, Silesian, Swietokrzyskie and West Pomeranian Voivodeship). All sites are selected through a tendering process and have to fulfil several criteria for inclusion into the project (active participation in the OCCSP, being certified for HPV testing with the chosen clinically validated hrHPV DNA assays)to obtain results representative for the entire country.
Gynaecological clinics:
Lublin Voivodeship:
Masovian Voivodeship:
Silesian Voivodeship:
Swietokrzyskie Voivodeship:
- Holy Cross Cancer Centre in Kielce
West Pomeranian Voivodeship:
Cytological&molecular laboratories
Colposcopy clinics
The primary endpoint is the detection rate (DR) of histologically confirmed CIN2 or higher in each screening arm and detection rate ratio (DRR) of CIN2+ in HPV test vs cytology arm in intention-to-treat (ITT) analysis. Secondary endpoints include detection rate ratio of CIN1+, CIN3+ (including adenocarcinoma in situ) and invasive CC in both ITT and per-protocol (PP) analysis, restricted to women who adhered to the foreseen follow-up.
Other outcome measures are: (1) distribution of women by the screening test results; (2) referral rate for colposcopy; (3) compliance with referral for colposcopy; (4) positive predictive value of referral for colposcopy calculated for each screening test and separately by histology results (no CIN, CIN1, CIN2, CIN3, AIS, CIN2+, CIN3+, invasive cancer (squamous/adenocarcinoma)); (5) DR of histologically confirmed CIN2+ in patients with hrHPV positive test, two NILM LBCs six months apart and a positive CINtePlus Cytology and/or Qiasure test; (6) DRR of histologically confirmed CIN2+ after CINtec® PLUS Cytology test vs. QIASURE methylation test; (7) yield of use of CINtec® PLUS Cytology test vs. QIASURE methylation test in terms of detection rate of histologically confirmed CIN2+.
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 was approved by the Bioethics Committee of National Research Institute of Oncology (ID: 28/2019/1/2020).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional exfoliative cytology/LBC | No Intervention | 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. | |
| hrHPV molecular testing | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Offering an alternative cervical cancer screening method - hrHPV molecular testing. | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of histologically confirmed CIN2 or worse in each screening arm | 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) | 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 | 12 months after the date of the positive screening test |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate ratio of CIN1+, CIN3+ (including adeno-carcinoma-in-situ) and cervical cancer (ITT). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of women by the screening test results | This is for conventional cytology and LBC - according the modified Bethesda 2014 system used in the program. We will analyze the number of women due to the result of screening test in each arm. | 12 months after the date of the positive screening test |
| Referral rate for colposcopy for each screening test |
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42403920 | Derived | Nowakowski A, Macios A, Glinska P, Chmielewska A, Janik B, Jedrzejewska I, Klimiuk A, Chmielik E, Bobkiewicz P, Kapusniak E, Podolski J, Prokurat E, Arbyn M, Kaminski MF. Primary Human Papillomavirus Screening Versus Cytology for Detection of Cervical Intraepithelial Neoplasia Grade 2 or Higher in Poland: a Parallel-Group, Randomized Controlled Trial. Lancet Reg Health Eur. 2026 May 8;66:101697. doi: 10.1016/j.lanepe.2026.101697. eCollection 2026 Jul. | |
| 37978452 |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 12 months after the date of the positive screening test |
Analyses will be performed on data collected in SIMP. We will check the compliance on referral for colposcopy for each screening. |
| 12 months after the date of the positive screening test |
| Positive predictive value of referral for colposcopy calculated for each screening test and separately | Histology: No CIN, CIN1, CIN2, CIN3, AIS, CIN2+, CIN3+, invasive cancer (squamous/adenocarcinoma). | 12 months after the date of the positive screening test |
| Detection rates of histologically confirmed CIN2+ in patients with second negative LBC result | Detection rates of histologically confirmed CIN2+ in patients with second negative LBC result: after CINtec PLUS Cytology test and after QIASURE methylation test; detection rate ratio of histologically confirmed CIN2+ after CINTEC test vs after QIASURE methylation test | 12 months after the date of the positive screening test |
| Yield of use of additional diagnostic tests in terms of detection rate of histologically confirmed CIN2+ | Number of women with histologically confirmed CIN2+ after CINtec test/number of women screened with HPV test | 12 months after the date of the positive screening test |
| Yield of use of additional diagnostic tests in terms of detection rate of histologically | Number of women with histologically confirmed CIN2+ after QIASURE methylation test/number of women screened with HPV test | 12 months after the date of the positive screening test |
| Derived |
| Glinska P, Komerska K, Janik B, Olkowicz J, Jedrzejewska I, Macios A, Wieszczy P, Kaminski MF, Arbyn M, Nowakowski A. HPV testing in Polish population-based cervical cancer screening programme (HIPPO project)-study protocol of a randomised healthcare policy trial. BMC Cancer. 2023 Nov 17;23(1):1118. doi: 10.1186/s12885-023-11597-5. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |