NCT07033091

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20,000 (estimated)
• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

One of the primary objectives of this study is to clarify the prevalence of oral infection with high-risk human papillomaviruses (hrHPV) in individuals over 40 years of age in the Czech Republic. This research will enable a more precise estimation of the population at risk for oropharyngeal carcinoma, which is essential for the development of targeted preventive and diagnostic strategies. Another key objective is to establish an effective methodology for oropharyngeal carcinoma screening and to optimize the associated testing procedures. To achieve these goals, participants will be recruited into two predefined cohorts. The first cohort will consist of healthy individuals recruited through cooperating dental and outpatient clinics. The second cohort will involve potential participants identified from available databases (e.g., clinical trial databases, commercial databases, health insurance records), who will be invited to participate via mailed self-collection kits for gargle sampling. For participants testing positive for oral hrHPV, venous blood samples will be collected at regular intervals to assess the presence of circulating hrHPV DNA. If hrHPV is detected in the oropharynx, participants will be offered self-collection HPV testing of the urogenital tract (cervicovaginal swabs for women or external genital swabs for men). In both cohorts, the study will evaluate the prevalence of oral (and, if applicable, genital) hrHPV infection, articipation rates, and the return rates of valid samples for hrHPV testing. Additionally, the study will monitor hrHPV persistence and plasma hrHPV DNA in individuals who test positive. Investigators anticipate that the results of this study will contribute to earlier and more effective diagnosis of oropharyngeal cancer, with potential for significant public health impact by reducing the burden of this disease. For individual participants, involvement in the study may provide an opportunity for clinical follow-up in the event of hrHPV positivity, supporting earlier detection of oropharyngeal carcinoma.

Conditions

• Oropharynx Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-sampling by gargling kit at dental clinic	Participants will perform a self-sampling at the dental clinic using gargling kit
OTHER	Questionnaire	Participants will answer questionnaire online/paper at their home or at the dental clinic
DIAGNOSTIC_TEST	Self-sampling by gargling kit at home	Participants will perform a self-sampling at home using gargling kit
DIAGNOSTIC_TEST	Blood 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_TEST	Self-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).

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-12-31
• Completion: 2031-03-30
• First posted: 2025-06-24
• Last updated: 2026-02-13

Locations

5 sites across 1 country: Czechia