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

The Institute of Molecular and Translational Medicine, Czech Republic

Status: Enrolling

Conditions: Oropharynx Cancer

Treatments: Diagnostic Test: Self-sampling by gargling kit at home; Other: Questionnaire; Diagnostic Test: Self-sampling by gargling kit at dental clinic; Diagnostic Test: Self-sampling of the urogenital area; Diagnostic Test: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT07033091

10000 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

We 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• Previously diagnosed head and neck cancer.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20,000 participants in 2 patient groups

Arm A

Experimental group

Description:

Participants over 40 years attending cooperating dental clinics, who agree to the study, complete questionnaire and provide self-sampled gargling sample. These will be tested by CE-IVD-marked HPV diagnostic test. This arm will include approx. 10000 participants.

Treatment:

Diagnostic Test: Blood sampling

Diagnostic Test: Self-sampling of the urogenital area

Other: Questionnaire

Diagnostic Test: Self-sampling by gargling kit at dental clinic

Arm B

Experimental group

Description:

Participants over 40 years selected from available databases receive by mail the study information, questionnaire and self-sampling gargling kit. The kits will be sent back to laboratory and will be tested by CE-IVD-marked HPV diagnostic test. This arm will include approx. 10000 participants.

Treatment:

Diagnostic Test: Blood sampling

Diagnostic Test: Self-sampling of the urogenital area

Diagnostic Test: Self-sampling by gargling kit at home

Other: Questionnaire