Clinical trial · Interventional
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
NCT04133610CI-TRIAL-00041922HPVProcompletedN/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)
Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.
Conditions
Conditions (3)
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 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-sampling using digene HC2 DNA Collection Device | Diagnostic Test | — | UNRESOLVED |
| Self-sampling using Evalyn Brush | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-sampling device in media
- description
- Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using self-sampling device in STM media. HPV will be detected by hybridization technique.
- interventionNames
- Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device
- type
- EXPERIMENTAL
- label
- Dry self-sampling device
- description
- Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using dry self-sampling device. HPV will be detected by hybridization and PCR techniques.
- interventionNames
- Diagnostic Test: Self-sampling using Evalyn Brush
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Women with age 30-64 years. * Women attending cervical cancer screening program in Czech Republic. * Women with completed informed consent. Exclusion Criteria: * Pregnant women. * Women with no sexual intercourse experience. * Women after cervical conization or hysterectomy. * Women with CIN or cervical carcinoma in anamnesis. * Women at risk of increased bleeding.
References
Publications (1)
- DERIVEDJaworek H, Bouska O, Kourilova P, Hajduch M, Koudelakova V. High-risk HPV prevalence in the Czech cervical cancer screening population: a comparison of clinician-collected and self-collected sampling. Eur J Public Health. 2025 Aug 1;35(4):760-765. doi: 10.1093/eurpub/ckaf045. PMID 40194781