Oropharynx CancerNCT07033091
Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
A study testing Self-sampling by gargling kit at dental clinic, Questionnaire and Self-sampling by gargling kit at home in people with Oropharynx Cancer, run by The Institute of Molecular and Translational Medicine, Czech Republic at 5 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Self-sampling by gargling kit at dental clinic, Questionnaire and Self-sampling by gargling kit at home
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 5 sitesCzechia
- Study dates
- 1 Jun 2025to 30 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previously diagnosed head and neck cancer.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Czechia5 sites, 5 recruiting
- Not yet recruiting
Masaryk Memorial Cancer Institute
Brno
Jana Halamaková, MD.
- Recruiting
Stomatologická klinika, Fakultní nemocnice u sv. Anny
Brno
Lydie Izakovičová Hollá, MD, PhD., +420 543 183 412, sekr.stk@fnusa.cz
Lydie Izakovičová Hollá, MD
- Recruiting
Stomatologické centrum ARTDENT s.r.o.
Jihlava, 586 01
Jana Vrbková, MD, +420 567 331 666, recepce@artdent.eu
Jana Vrbková, MD
- Recruiting
Klinika zubního lékařství Fakultní nemocnice Olomouc
Olomouc, 77900
Iva Voborná, MD, +420585859229, iva.voborna@fnol.cz
Iva Voborná, MD
- Recruiting
CLINIQ Dejvice
Prague, 160 00
Valerie Burešová, Mgr., +420 731 705 707, recepce@cliniqdejvice.cz
Jakub Studený, MDDr., +420 731 705 707, recepce@cliniqdejvice.cz
About this study
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.
Read the 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
- Being tested
- Self-sampling by gargling kit at dental clinic, Questionnaire, Self-sampling by gargling kit at home, Blood sampling, Self-sampling of the urogenital area
- Keywords
- Human Papillomavirus, HPV Infection, oropharyngeal cancer
- Medical subject headings
- Oropharyngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-sampling by gargling kit at dental clinicDiagnostic test
Participants will perform a self-sampling at the dental clinic using gargling kit
QuestionnaireOther
Participants will answer questionnaire online/paper at their home or at the dental clinic
Self-sampling by gargling kit at homeDiagnostic test
Participants will perform a self-sampling at home using gargling kit
Blood samplingDiagnostic test
Venous blood will be collected from study participants with oral hrHPV positivity, in which the presence of circulating hrHPV DNA will be determined.
Self-sampling of the urogenital areaDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaire; Diagnostic Test: Self-sampling by gargling kit at home; Diagnostic Test: Blood sampling; Diagnostic Test: Self-sampling of the urogenital area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, Ph.D., Study director, Faculty of Medicine and Dentistry, Palacky University, Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033091
- Sponsor's protocol ID
- 10000
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
- ClinicalTrials.gov ID
- NCT07033091
- Acronym / sponsor ID
- 10000
- Conditions
- Oropharynx Cancer
- Keywords
- Human Papillomavirus, HPV Infection, oropharyngeal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Diagnostic Test: Self-sampling by gargling kit at dental clinic, Other: Questionnaire, Diagnostic Test: Blood sampling, Diagnostic Test: Self-sampling of the urogenital areaParticipants 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. |
| Arm B | Experimental | Other: Questionnaire, Diagnostic Test: Self-sampling by gargling kit at home, Diagnostic Test: Blood sampling, Diagnostic Test: Self-sampling of the urogenital areaParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Previously diagnosed head and neck cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-sampling by gargling kit at dental clinicParticipants will perform a self-sampling at the dental clinic using gargling kit | Diagnostic test | Arm A |
| QuestionnaireParticipants will answer questionnaire online/paper at their home or at the dental clinic | Other | Arm A, Arm B |
| Self-sampling by gargling kit at homeParticipants will perform a self-sampling at home using gargling kit | Diagnostic test | Arm B |
| Blood samplingVenous blood will be collected from study participants with oral hrHPV positivity, in which the presence of circulating hrHPV DNA will be determined. | Diagnostic test | Arm A, Arm B |
| Self-sampling of the urogenital areaIn 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). | Diagnostic test | Arm A, Arm B |
Primary outcome
Oral prevalence of high-risk HPV
Time frame: 24 months
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.
Establishment of an effective methodology applicable to oropharyngeal cancer screening
Time frame: 24 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marian Hajduch, Ph.D. study director
Faculty of Medicine and Dentistry, Palacky University, Olomouc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling by gargling kit at dental clinic, Questionnaire and Self-sampling by gargling kit at home in people with Oropharynx Cancer, run by The Institute of Molecular and Translational Medicine, Czech Republic at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimira Koudelakova, Ph.D. (+420585632089, vladimira.koudelakova@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral prevalence of high-risk HPV (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.