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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07033091
Enrollment
20000
Registered
2025-06-24
Start date
2025-06-01
Completion date
2031-03-30
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharynx Cancer

Keywords

Human Papillomavirus, HPV Infection, oropharyngeal cancer

Brief 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.

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).

Sponsors

The Institute of Molecular and Translational Medicine, Czech Republic
Lead SponsorOTHER
National Institute for Cancer Research, Czech Republic
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oral prevalence of high-risk HPV24 monthsNumber 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 screening24 monthsEstablishment 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.

Countries

Czechia

Contacts

CONTACTVladimira Koudelakova, Ph.D.
vladimira.koudelakova@upol.cz+420585632089
STUDY_DIRECTORMarian Hajduch, Ph.D.

Faculty of Medicine and Dentistry, Palacky University, Olomouc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026