Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
NCT ID: NCT07033091
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20000 participants
INTERVENTIONAL
2025-06-01
2031-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm A
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.
Self-sampling by gargling kit at dental clinic
Participants will perform a self-sampling at the dental clinic using gargling kit
Questionnaire
Participants will answer questionnaire online/paper at their home or at the dental clinic
Blood sampling
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 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).
Arm B
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.
Questionnaire
Participants will answer questionnaire online/paper at their home or at the dental clinic
Self-sampling by gargling kit at home
Participants will perform a self-sampling at home using gargling kit
Blood sampling
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 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).
Interventions
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Self-sampling by gargling kit at dental clinic
Participants will perform a self-sampling at the dental clinic using gargling kit
Questionnaire
Participants will answer questionnaire online/paper at their home or at the dental clinic
Self-sampling by gargling kit at home
Participants will perform a self-sampling at home using gargling kit
Blood sampling
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 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).
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
ALL
Yes
Sponsors
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National Institute for Cancer Research, Czech Republic
OTHER
The Institute of Molecular and Translational Medicine, Czech Republic
OTHER
Responsible Party
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Principal Investigators
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Marian Hajduch, Ph.D.
Role: STUDY_DIRECTOR
Faculty of Medicine and Dentistry, Palacky University, Olomouc
Locations
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Klinika zubního lékařství Fakultní nemocnice Olomouc
Olomouc, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10000
Identifier Type: -
Identifier Source: org_study_id
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