Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.
Comparative Study of Breast Cancers and Their Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.
Descripción general del estudio
Descripción detallada
An epidemiologic study looks at the patterns, causes, and control of disease in groups of people. Researchers want to see if various risk factors (such as decreased and delayed fertility, obesity, and a sedentary [low physical activity] lifestyle) and certain markers that cause breast cancer are different in women in the above groups.
If you have breast cancer and you agree to take part in this study, you will be interviewed by a trained interviewer with a questionnaire at a time convenient for you, either during your visit to MD Anderson or The Rose, or by phone. You will be asked questions about your personal demographics (such as your age and race), environmental exposures, medical history, family history of cancer, and other day-to-day lifestyle factors. It should take about 30-40 minutes to complete the interview. Clinical data about your breast cancer treatment will also be collected from your medical records.
You will also have a one-time blood draw (about 3 tablespoons). If blood cannot be drawn or not enough blood can be drawn, you will have a saliva sample taken where you will be required to spit into a container. If you have already donated blood or a saliva sample in the Mexican-American Cohort Study, a portion of that sample may be used instead of having to collect a new sample. Your blood or saliva sample will be used to look at your DNA (genetic material of cells). The study pathologist will look at possible prognostic markers (substances that predict outcome of disease) from tissue obtained from your surgery.
Neither you nor your regular doctor will receive reports of this research study. The results of this research study will not be placed in your health records. All of your information obtained in this study will be kept confidential either in a password-protected computer or in a locked file cabinet in a secure location.
Your participation will be over in this study when all the data has been collected and analyzed.
This is an investigational study. Up to 1,825 women will take part in this multicenter study. Up to 1125 will be enrolled at MD Anderson.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Tucson, Arizona, Estados Unidos, 85724-5024
- Arizona Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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Houston, Texas, Estados Unidos, 77030
- LBJ Hospital
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Houston, Texas, Estados Unidos, 77034
- The Rose Diagnostic Center
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Ciudad Obregon, México
- Instituto Tecnologico
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Guadalajara, México
- University of Guadalajara
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Sonora
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Hermosillo, Sonora, México
- University of Sonora
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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
Descripción
Inclusion Criteria:
- All women of Mexican and African descent ages 18 years or older.
- Diagnosis of invasive breast cancer (histologically confirmed invasive adenocarcinoma, including ductal, lobular, medullary, tubular and mucinous cellular patterns) within the past 24 months.
- Willing to complete a questionnaire.
- Consent to tissue acquisition (remaining after surgery or preoperative core needle biopsy).
Exclusion Criteria:
- Male gender
- Inadequate tissue obtained for the four main clinical markers (ER, PR, Her-2/neu and Ki67).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Mexican Women from Mexico
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Interview and survey during visit or by phone, 30 - 40 minutes.
Otros nombres:
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Mexican-American Women in U.S.
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Interview and survey during visit or by phone, 30 - 40 minutes.
Otros nombres:
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African-American Women in U.S.
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Interview and survey during visit or by phone, 30 - 40 minutes.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Categorical Response Variables
Periodo de tiempo: 5 years
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5 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Expression of a breast tumor phenotype marker (expressed versus not expressed)
Periodo de tiempo: 5 Years
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5 Years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
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
- 2006-0551
- 3P50CA116199-02S1 (Subvención/contrato del NIH de EE. UU.)
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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