Clinical trial · Interventional
HPV Testing In Polish POpulation-based Cervical Cancer Screening Program.
HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
NCT04111835CI-TRIAL-00073583HIPPOPROJECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Offering an alternative cervical cancer screening method - hrHPV molecular testing. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional exfoliative cytology/LBC
- description
- 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.
- type
- EXPERIMENTAL
- label
- hrHPV molecular testing
- description
- 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
- interventionNames
- Diagnostic Test: Offering an alternative cervical cancer screening method - hrHPV molecular testing.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNowakowski 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. PMID 42403920
- DERIVEDGlinska 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. PMID 37978452