Detección de carcinoma nasofaríngeo con biomarcadores asociados al EBV en la ciudad de Zhongshan
Búsqueda de biomarcadores de detección temprana de carcinoma nasofaríngeo en la ciudad de Zhongshan
The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Sample selection
- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
- Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
- Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
- At initial screening, all participants in both cohorts will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in the serological and EBV DNA screening cohort, EBV-DNA will be tested. Consecutive EBV DNA positivity is defined as positive plasma EBV DNA results at both baseline and repeat testing approximately 4 weeks later. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or consecutive EBV DNA positive. The rest will be screening negative.
- During the initial screening and following up, people with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
- Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
- EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
- The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
- All subjects will also be followed by record linkage to Cancer Register and Population Register.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mingfang Ji, MD
- Número de teléfono: 86-760-89880417
- Correo electrónico: jmftbh@sina.com
Ubicaciones de estudio
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Guangdong
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Zhongshan, Guangdong, Porcelana, 528403
- Reclutamiento
- Zhongshan People's Hospital
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Contacto:
- Mingfang Ji, MD
- Correo electrónico: jmftbh@sina.com
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Investigador principal:
- Mingfang Ji, MD
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Guangxi
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Wuzhou, Guangxi, Porcelana, 543002
- Reclutamiento
- Wuzhou Red Cross Hospital
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Contacto:
- Yonglin Cai, MD
- Correo electrónico: cylzen@hotmail.com
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Investigador principal:
- Yonglin Cai, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Descripción
Inclusion Criteria:
- Subject residents in Zhongshan City or Wuzhou City
- Subject has no medical record of nasopharyngeal carcinoma
- ECOG 0-2
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Exclusion Criteria:
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Serological screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy |
|
Serological and EBV DNA screening cohort
30-69 years old healthy participants. |
Collect blood and saliva samples from participants Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy All participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sensitivity and specificity of different EBV associated biomarkers
Periodo de tiempo: 5 years
|
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC |
5 years
|
|
Positive and negative predictive values of different EBV associated biomarkers
Periodo de tiempo: 5 years
|
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC |
5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number needed to screen to identify one nasopharyngeal carcinoma
Periodo de tiempo: 5 years
|
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers |
5 years
|
|
Early diagnosis rate of nasopharyngeal carcinoma
Periodo de tiempo: 5 years
|
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma |
5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The health economic benefits of different biomarkers for nasopharyngeal carcinoma
Periodo de tiempo: 5 years
|
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers |
5 years
|
|
New screening strategy of nasopharyngeal carcinoma screening
Periodo de tiempo: 5 years
|
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma |
5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Estomatognáticas
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Enfermedades Otorrinolaringológicas
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Enfermedades Nasofaríngeas
- Enfermedades faríngeas
- Neoplasias Nasofaríngeas
- El carcinoma nasofaríngeo
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Técnicas citológicas
- Citodiagnóstico
- Técnicas de diagnóstico, quirúrgico
- Biopsia
- Recolección de muestras de sangre
Otros números de identificación del estudio
- NPC-PRO-003
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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