Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic

About this trial

This study defines the prevalence of oral infection with high-risk human papillomaviruses (hrHPV) in individuals over 40 years of age in the Czech Republic. It also establishes an effective methodology for oropharyngeal carcinoma screening and optimization of screening and testing procedures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants aged 40 years or older at the time of enrollment.

Individuals who are capable of rinsing the oral cavity by gargling independently.

Signed informed consent for study participation, molecular-genetic testing, and personal data processing.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self-sampling by gargling kit at dental clinic

    Diagnostic test

    Participants will perform a self-sampling at the dental clinic using gargling kit

  • Questionnaire

    Other intervention

    Participants will answer questionnaire online/paper at their home or at the dental clinic

  • Self-sampling by gargling kit at home

    Diagnostic test

    Participants will perform a self-sampling at home using gargling kit

  • Blood sampling

    Diagnostic test

    Venous blood will be collected from study participants with oral hrHPV positivity, in which the presence of circulating hrHPV DNA will be determined.

  • Self-sampling of the urogenital area

    Diagnostic test

    In case of a positive examination in the oropharynx, the tested individuals will be offered a self-collection HPV examination in the urogenital area (cervicovaginal swab in women or external genital swab in men).

Treatment groups

20,000 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 4 interventions
Group B: Arm BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Oral prevalence of high-risk HPV

Number of participants with oral infection with high-risk human papillomaviruses (hrHPV) in the Czech Republic in individuals over 40 years of age will be determined. This will enable a more accurate estimation of the population at risk for oropharyngeal cancer.

Time frame
24 months
2

Establishment of an effective methodology applicable to oropharyngeal cancer screening

Establishment of an effective methodology applicable to oropharyngeal cancer screening and optimization of the testing procedure to clarify the prevalence of oral infection with high-risk HPV.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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The Institute of Molecular and Translational Medicine, Czech Republic

Lead sponsor

National Institute for Cancer Research, Czech Republic

Collaborator