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NCT05578833: LIBUSE
Algorithm for Cervix Carcinoma Screening in CZ Using the Detection of HPV DNA and CINtec Plus
trial testing HPV DNA test with selective HPV 16/18 genotyping (cobas® 4800 HPV Test, Roche) in Algorithm for Cervix Carcinoma Screening in 2,426 participants. Completed in 30 September 2021.
20 April 2018
Quick facts
| Lead sponsor | AeskuLab Pathology Prague |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,426 |
| Start date | 1 September 2017 |
| Primary completion | 20 April 2018 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- HPV DNA test with selective HPV 16/18 genotyping (cobas® 4800 HPV Test, Roche)
- p16 and Ki-67 biomarker detection in the form of dual cytological staining (CINtec Plus, Roche)
- standard conventional cytology PAP test
Conditions studied
- Algorithm for Cervix Carcinoma Screening — all drugs for Algorithm for Cervix Carcinoma Screening →
Sponsor
AeskuLab Pathology Prague
Who can join
Adults 30 to 60, female only, with Algorithm for Cervix Carcinoma Screening. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening?
Sláma J, Dvořák V, Trnková M, Skřivánek A, et al · · 2024 · PMID 37751376 · DOI 10.1097/cej.0000000000000844
Verify or expand the search:
- PubMed search for NCT05578833
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05578833 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AeskuLab Pathology Prague
- Last refreshed: 13 October 2022
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