RecruitingNot ApplicableNCT07033091

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

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Enrollment

20,000 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Oropharynx Cancer

Summary

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

Min Age: 40 Years

Inclusion Criteria3

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.

Exclusion Criteria1

\- Previously diagnosed head and neck cancer.

Interventions

DIAGNOSTIC_TESTSelf-sampling by gargling kit at dental clinic

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

OTHERQuestionnaire

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

DIAGNOSTIC_TESTSelf-sampling by gargling kit at home

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

DIAGNOSTIC_TESTBlood sampling

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

DIAGNOSTIC_TESTSelf-sampling of the urogenital area

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).