Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Self-sampling by gargling kit at dental clinic, Questionnaire, Self-sampling by gargling kit at home, Blood sampling.
- Кому может быть актуально
- Состояния в реестре: Oropharynx Cancer. Базовые параметры: от 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест Self-sampling by gargling kit at dental clinic
Participants will perform a self-sampling at the dental clinic using gargling kit - Другое Questionnaire
Participants will answer questionnaire online/paper at their home or at the dental clinic - Диагностический тест Self-sampling by gargling kit at home
Participants will perform a self-sampling at home using gargling kit - Диагностический тест 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. - Диагностический тест 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).
Первичные конечные точки
- Oral prevalence of high-risk HPV [Срок оценки: 24 months]
- Establishment of an effective methodology applicable to oropharyngeal cancer screening [Срок оценки: 24 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
\- Previously diagnosed head and neck cancer.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
Чехия · 5 центров
- Masaryk Memorial Cancer Institute — Brno
- Stomatologická klinika, Fakultní nemocnice u sv. Anny — Brno
- Stomatologické centrum ARTDENT s.r.o. — Jihlava
- Klinika zubního lékařství Fakultní nemocnice Olomouc — Olomouc
- CLINIQ Dejvice — Prague
Идентификаторы
NCT: NCT07033091 · 10000