Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection
Conditions
Keywords
human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSelf-sampling using digene HC2 DNA Collection Device
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
DIAGNOSTIC_TESTSelf-sampling using Evalyn Brush
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Sponsors
National Institute for Cancer Research, Czech Republic
The Institute of Molecular and Translational Medicine, Czech Republic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV prevalence | 18 months | Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women. |
| Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs | 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs. | 18 months | 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. |
Countries
Czechia
Outcome results
None listed