Measuring how common high-risk oral HPV is in adults over 40 and testing a screening method for oropharyngeal cancer in the Czech Republic.
Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
This project will test a simple gargle self-sampling method, with follow-up blood and genital self-tests when needed, to see how common high-risk oral HPV is in people aged 40 and over in the Czech Republic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic Academic / other |
| Locations | 5 sites (Brno and 4 other locations) |
| Trial ID | NCT07033091 on ClinicalTrials.gov |
What this trial studies
The study recruits adults 40 and older into two cohorts: healthy volunteers through dental and outpatient clinics and people invited by mailed self-collection gargle kits from databases. Participants provide a gargle sample for HPV DNA testing, complete a questionnaire, and those with oral high-risk HPV will have periodic blood samples to check for circulating HPV DNA and be offered urogenital self-sampling. The project will measure oral (and, if applicable, genital) hrHPV prevalence, participation and return rates for mailed kits, and refine screening and laboratory procedures. The aim is to establish an effective, feasible methodology for oropharyngeal carcinoma screening and optimize associated testing procedures.
Who should consider this trial
Good fit: Adults aged 40 or older who can gargle independently, have no prior head and neck cancer, and can give informed consent are ideal candidates.
Not a fit: People under 40, those previously diagnosed with head and neck cancer, or individuals unable to perform gargling or self-sampling are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could help identify people at higher risk for oropharyngeal cancer earlier using simple self-sampling and inform targeted prevention and follow-up.
How similar studies have performed: Oral self-sampling and HPV DNA testing have shown promise in research for detecting oral hrHPV, but organized population screening for oropharyngeal cancer is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brno and 4 other locations
- Masaryk Memorial Cancer Institute — Brno, Czechia (Not_yet_recruiting)
- Stomatologická klinika, Fakultní nemocnice u sv. Anny — Brno, Czechia (Recruiting)
- Stomatologické centrum ARTDENT s.r.o. — Jihlava, Czechia (Recruiting)
- Klinika zubního lékařství Fakultní nemocnice Olomouc — Olomouc, Czechia (Recruiting)
- CLINIQ Dejvice — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Vladimira Koudelakova, Ph.D.
- Email: vladimira.koudelakova@upol.cz
- Phone: +420585632089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.