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

Not Applicable

Completed

• Conditions: Human Papillomavirus Infection; Cervical Cancer; Cervical Dysplasia
• Interventions: Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device; Diagnostic Test: Self-sampling using Evalyn Brush

• Registration Number: NCT04133610
• Lead Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Primary Completion: 2019-10-30
• Status Verified: 2019-11
• Study Completion: 2019-11-25
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1044

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-sampling device in media	Self-sampling using digene HC2 DNA Collection Device	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	Self-sampling using Evalyn Brush	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

GYNPRENATAL, Ltd.; 🇨🇿 Havířov, Czechia

GYN-PREN, Ltd.; 🇨🇿 Frýdek-Místek, Czechia

MEDIOL, Ltd.; 🇨🇿 Olomouc, Czechia