HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs

The Institute of Molecular and Translational Medicine, Czech Republic1,044 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

1,044

Conditions

Cervical Cancer Cervical Dysplasia Human Papillomavirus Infection

Interventions

Self-sampling using digene HC2 DNA Collection DeviceDIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Self-sampling using Evalyn BrushDIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

GYN-PREN, Ltd.

Frýdek-Místek, Czechia

GYNPRENATAL, Ltd.

Havířov, Czechia

MEDIOL, Ltd.

Olomouc, Czechia

Outcomes

Primary Outcomes

HPV prevalence

Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.

Time frame: 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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 18 months

Data from ClinicalTrials.gov

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