Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 5
- 主要终点
- Oral prevalence of high-risk HPV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- Previously diagnosed head and neck cancer.
研究组 & 干预措施
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.
干预措施: Self-sampling by gargling kit at dental clinic (Diagnostic Test)
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.
干预措施: Questionnaire (Other)
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.
干预措施: Blood sampling (Diagnostic Test)
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.
干预措施: Self-sampling of the urogenital area (Diagnostic Test)
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.
干预措施: Questionnaire (Other)
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.
干预措施: Self-sampling by gargling kit at home (Diagnostic Test)
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.
干预措施: Blood sampling (Diagnostic Test)
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.
干预措施: Self-sampling of the urogenital area (Diagnostic Test)
结局指标
主要结局
Oral prevalence of high-risk HPV
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点