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

NCT07033091 | Recruiting

• 1 other identifier: 10000
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Oropharynx Cancer

Keywords

Human Papillomavirus; HPV Infection; oropharyngeal cancer

Outcome Measures

Primary Outcomes (2)

• Oral prevalence of high-risk HPV

  Number 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.

  24 months

• Establishment of an effective methodology applicable to oropharyngeal cancer screening

  Establishment 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.

  24 months

Study Arms (2)

Arm A

EXPERIMENTAL

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.

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

Arm B

EXPERIMENTAL

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.

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

Interventions

Self-sampling by gargling kit at dental clinic DIAGNOSTIC_TEST

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

Arm A

Questionnaire OTHER

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

Arm A; Arm B

Self-sampling by gargling kit at home DIAGNOSTIC_TEST

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

Arm B

Blood sampling DIAGNOSTIC_TEST

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

Arm A; Arm B

Self-sampling of the urogenital area DIAGNOSTIC_TEST

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).

Arm A; Arm B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Previously diagnosed head and neck cancer.

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead
• National Institute for Cancer Research, Czech Republic: collaborator

Study Sites (5)

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, 586 01, Czechia

RECRUITING

Klinika zubního lékařství Fakultní nemocnice Olomouc

Olomouc, 77900, Czechia

RECRUITING

CLINIQ Dejvice

Prague, 160 00, Czechia

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Papillomavirus Infections

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Marian Hajduch, Ph.D.

  Faculty of Medicine and Dentistry, Palacky University, Olomouc

  STUDY DIRECTOR

Central Study Contacts

Vladimira Koudelakova, Ph.D.

CONTACT

+420585632089; vladimira.koudelakova@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): March 30, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CZ (5)