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| Name | Class |
|---|---|
| National Institute for Cancer Research, Czech Republic | OTHER |
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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.
The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-sampling device in media | Experimental | 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. |
|
| Dry self-sampling device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-sampling using digene HC2 DNA Collection Device | Diagnostic Test | All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HPV prevalence | Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women. | 18 months |
| Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs | Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs. | Hybridization and PCR-based HPV detection methods will be tested in both cervical and cervicovaginal swabs and results of these two methods will be compared. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marian Hajduch, MD, PhD. | Palacky University in Olomouc, Faculty of Medicine and Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GYN-PREN, Ltd. | Frýdek-Místek | Czechia | ||||
| GYNPRENATAL, Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40194781 | Derived | Jaworek 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. |
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| Self-sampling using Evalyn Brush | Diagnostic Test | All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab. |
|
| Havířov |
| Czechia |
| MEDIOL, Ltd. | Olomouc | Czechia |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D011230 | Precancerous Conditions |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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