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Completed

NCT Number: NCT04133610

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

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.

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Key information

Conditions

Cervical Cancer Cervical Dysplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GYN-PREN, Ltd., Frýdek-Místek, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-sampling using digene HC2 DNA Collection Device

Diagnostic Test

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

Self-sampling using Evalyn Brush

Diagnostic Test

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

Primary outcomes

  1. HPV prevalence

    Time frame: 18 months

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

  2. Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs

    Time frame: 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 outcomes

  1. Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • National Institute for Cancer Research, Czech Republic

Registry information

Acronym: HPVPro

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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