- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02358070
Epidemiologic Study of Hepatocellular Carcinoma in the US
The purpose of this study is:
- to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.
- to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.
- to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford Liver Transplant Clinic
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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
All patients with Hepatocellular Carcinoma in New Jersey and Connecticut as well as selected patients in New York, Hawaii and northern California.
Healthy volunteers will comprise a random sample of New Jersey and Connecticut residents as controls.
Descripción
Inclusion Criteria for HCC cases:
- a diagnosis of primary liver cancer (excluding secondary tumors)
- a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder)
- a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence)
- a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer;
- age at diagnosis between 35 and 84 years
- living in Connecticut, New Jersey, New York, or Hawaii for at least a year as regular residents.
Exclusion Criteria for HCC cases:
- uncertain diagnoses or classification of malignancy, such as unknown origin
- a diagnosis of primary tumors in other organs, not in the liver
- unable to communicate well enough in English or Spanish
- having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent.
- diagnosed at age <35 years or >84 years
- temporary residents of New Jersey, Connecticut, New York, or Hawaii
Inclusion Criteria for control subjects:
- age between 35 and 84 years
- living in New Jersey or Connecticut for at least a year as regular residents
- able to communicate well in English or Spanish
- having no medical conditions, such as mental disorders, that prevent them from providing adequately comprehensible information
- potential subjects with a previous history of cancer are eligible.
Exclusion Criteria for control subjects:
- age < 35 years or > 84 years
- temporary residents of New Jersey or Connecticut
- unable to speak English or Spanish
- cannot provide adequately comprehensible information
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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grupo de control
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HCC group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lifetime physical activity
Periodo de tiempo: 20 years
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Lifetime physical activity will be measured by collecting data on major types of physical activity separately and by determining frequency, intensity, and duration of each activity using a combined modification of Friedenreich's lifetime physical activity questionnaire and Kriska's past year physical activity questionnaires.
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20 years
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Energy intake
Periodo de tiempo: 20 years
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A modified Food Frequency questionnaire based on one developed by Dr. Alan Kristal from the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle will capture energy intake by differentiating low-fat food options from higher-fat counterparts.
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20 years
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Lifestyle factors
Periodo de tiempo: 20 years
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Structured questionnaires will be used to elicit information on demographic, anthropometric, and socioeconomic factors, long-term use of medications, medical history, and family history of cancer, cigarette smoking and alcohol consumption, physical activity, and dietary habits.
Additional information unrelated to liver cancer will be included in the questionnaire to help assess possible recall bias.
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20 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mindie Nguyen, MD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Otros números de identificación del estudio
- HEP0049
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .