Clinical trial · Observational
Algorithm for Cervix Carcinoma Screening in CZ Using the Detection of HPV DNA and CINtec Plus
Algorithm for Cervix Carcinoma Screening in the Czech Republic Using the Detection of HPV DNA With Selective HPV 16/18 Genotype and Special CINtec Plus Cytological Colouring
- 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)
Cervix carcinoma has been a serious, long-term issue in the Czech Republic. The cause of nearly all cervix carcinomas is human papilomavirus (HPV). Hence the detection of the HPV genome is a more prospective screening tool with higher sensitivity than a cytological swab. As shown by comparative studies, the sensitivity of the HPV DNA test in the detection of severe pre-cancer is 35% higher on average when compared to the cytological test. The study repeatedly determined the presence of the HPV genome, including the prevalence of selected HPV genotypes (16, 18 and other hrHPV) and conventional cytology. The relative sensitivity of the two methods was specified. In the course of the prospective follow-up, the incidence of pre-cancers and invasive tumours in the study population were specified.
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 |
|---|---|---|---|
| Algorithm for Cervix Carcinoma Screening | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV DNA test with selective HPV 16/18 genotyping (cobas® 4800 HPV Test, Roche) | Diagnostic Test | — | UNRESOLVED |
| p16 and Ki-67 biomarker detection in the form of dual cytological staining (CINtec Plus, Roche) | Diagnostic Test | — | UNRESOLVED |
| standard conventional cytology PAP test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of hrHPV positivity in the Czech population
- timeFrame
- 49 months
- description
- The ratio of patients with a positive HPV test in the first combined screening episode and the number of examined women.
Secondary outcomes (4)
- measure
- Specification of prevalence of selected hrHPV genotypes
- timeFrame
- 49 months
- description
- Representation of individual hrHPV genotypes in the first and the second screening episode in all examined women and in all HPV positive women.
- measure
- Detection level of pre-cancers and invasive carcinomas in the first combined screening episode (indicator of relative sensitivity of the two methods)
- timeFrame
- 49 months
- description
- The ratio of detected diseases and the number of examined women in the first screening episode, a secondary endpoint.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signature * Age 30 - 60 * Screening (not reviewing after previous abnormal cytological finding) * Sampling of gravid women possible Exclusion Criteria: * Refusal to take part
References
Publications (14)
- BACKGROUNDKhan MJ, Castle PE, Lorincz AT, Wacholder S, Sherman M, Scott DR, Rush BB, Glass AG, Schiffman M. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005 Jul 20;97(14):1072-9. doi: 10.1093/jnci/dji187. PMID 16030305
- BACKGROUNDKjaer SK, Frederiksen K, Munk C, Iftner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl Cancer Inst. 2010 Oct 6;102(19):1478-88. doi: 10.1093/jnci/djq356. Epub 2010 Sep 14. PMID 20841605
- BACKGROUNDMcMenamin M, McKenna M, McDowell A. Clinical Utility of CINtec PLUS Triage in Equivocal Cervical Cytology and Human Papillomavirus Primary Screening. Am J Clin Pathol. 2018 Oct 24;150(6):512-521. doi: 10.1093/ajcp/aqy073. PMID 30169728
- BACKGROUNDMeijer CJ, Berkhof J, Castle PE, Hesselink AT, Franco EL, Ronco G, Arbyn M, Bosch FX, Cuzick J, Dillner J, Heideman DA, Snijders PJ. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009 Feb 1;124(3):516-20. doi: 10.1002/ijc.24010. PMID 18973271
- BACKGROUNDPetry KU, Schmidt D, Scherbring S, Luyten A, Reinecke-Luthge A, Bergeron C, Kommoss F, Loning T, Ordi J, Regauer S, Ridder R. Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 Dual-stained cytology. Gynecol Oncol. 2011 Jun 1;121(3):505-9. doi: 10.1016/j.ygyno.2011.02.033. Epub 2011 Mar 21. PMID 21420158
- BACKGROUNDRijkaart DC, Berkhof J, Rozendaal L, van Kemenade FJ, Bulkmans NW, Heideman DA, Kenter GG, Cuzick J, Snijders PJ, Meijer CJ. Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):78-88. doi: 10.1016/S1470-2045(11)70296-0. Epub 2011 Dec 14.