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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Human Papillomavirus Infection; Cervical Dysplasia
• Intervention / Treatment: Diagnostic test: Self-sampling using digene HC2 DNA Collection Device; Diagnostic test: Self-sampling using Evalyn Brush

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 Type: Interventional
• Enrollment (Actual): 1044
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Frýdek-Místek, Czechia
    • GYN-PREN, Ltd.
  • Havířov, Czechia
    • GYNPRENATAL, Ltd.
  • Olomouc, Czechia
    • MEDIOL, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-sampling device in media; 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.	Diagnostic test: Self-sampling using digene HC2 DNA Collection Device; All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Experimental: Dry self-sampling device; 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.	Diagnostic test: Self-sampling using Evalyn Brush; All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Collaborators: Cancer Research Czech Republic
• Investigators: Study Director: Marian Hajduch, MD, PhD., Palacky University in Olomouc, Faculty of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: HPV; human papillomavirus; self-sampling; cervical cancer screening; cervicovaginal swab; cervical swab
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; DNA Virus Infections; Tumor Virus Infections; Precancerous Conditions; Carcinoma in Situ; Uterine Cervical Neoplasms; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia; Papillomavirus Infections
• Other Study ID Numbers: 343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No