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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Self-sampling by gargling kit at dental clinic
Diagnostic testParticipants will perform a self-sampling at the dental clinic using gargling kit
Questionnaire
Other interventionParticipants will answer questionnaire online/paper at their home or at the dental clinic
Self-sampling by gargling kit at home
Diagnostic testParticipants will perform a self-sampling at home using gargling kit
Blood sampling
Diagnostic testVenous 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 testIn 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
Trial outcomes
Primary outcomes
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.
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.
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