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

The Institute of Molecular and Translational Medicine, Czech Republic

Status: Completed

Conditions: Human Papillomavirus Infection; Cervical Dysplasia; Cervical Cancer

Treatments: Diagnostic Test: Self-sampling using Evalyn Brush; Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04133610

343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,044 patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,044 participants in 2 patient groups

Self-sampling device in media

Experimental group

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.

Treatment:

Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device

Dry self-sampling device

Experimental group

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.

Treatment:

Diagnostic Test: Self-sampling using Evalyn Brush