- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01138345
Biomarkers in Blood Samples From Older Breast Cancer Survivors
The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in blood samples from older women with stage I, stage II, or stage III breast cancer who have finished primary therapy or breast cancer survivors.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
Primary
- To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy followed by endocrine therapy (cohort 2) versus surgery with or without radiotherapy followed by chemotherapy and with or without endocrine therapy (cohort 3) .
- To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy (cohort 1) versus women treated in cohort 2.
- To compare normalized p16^INK4a gene expression between cohorts 1, 2, and 3 versus an age-matched contemporaneous control group of healthy volunteers accrued from a separate study (cohort 4).
Secondary
- To access functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, nutritional status, and health-behavior status of these patients.
Tertiary (exploratory)
- To compare methodologies of p16 ^INK4a gene expression measurement in 50 patients in order to develop a batchable and analytically validated assay that eliminates the need for rapid sample processing.
- To explore any association between p16^INK4a expression and amount of vigorous physical activity, smoking habits, and/or weekly alcohol consumption.
- To explore any association between p16^INK4a expression and type of chemotherapy received, co-morbidities, concomitant medications, and/or tumor characteristics.
- To correlate p16^INK4a expression with scores from selected domains of the Geriatric Assessment (i.e., cognitive function, activities of daily living (ADL), and the instrumental ADL.
OUTLINE: Breast cancer survivors and healthy volunteers undergo blood collection for p16^INK4a gene expression analysis by Taqman RT-PCR.
Breast cancer survivors complete the Health Behavior and the Geriatric Assessment Questionnaires. They also complete a Timed Up and Go test to determine physical mobility.
Medical charts are reviewed to record information about diagnosis and treatment.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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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
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
- Stage I-III disease
Breast cancer survivors meeting 1 of the following criteria:
- Prior surgery with or without (±) radiotherapy (RT) (cohort 1)
Prior surgery ± RT, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)
- Must have received or be on endocrine therapy for ≥ 3 months
- Prior surgery ± RT, followed by prior chemotherapy ± endocrine therapy (cohort 3)
- No recurrent disease
- No history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)
PATIENT CHARACTERISTICS:
- Life expectancy > 12 months
- Absolute lymphocyte count > 500/μL
- No acute or active infection
- No other co-morbid illness that would impair ability to participate in the study
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 months since prior surgery with or without radiotherapy
- At least 3 months since prior chemotherapy (cohort 3)
- No concurrent radiotherapy, chemotherapy, or experimental therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
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blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
each cohort will be given the same questionnaire
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Treatment w/endocrine therapy
Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.
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blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
each cohort will be given the same questionnaire
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Treatment w/ chemotherapy
Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy.
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blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
each cohort will be given the same questionnaire
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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p16INK4a expression between cohort 2 vs cohort 3
Periodo de tiempo: 2 years
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2 years
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p16INK4a expression between cohort 1 vs cohort 2
Periodo de tiempo: 2 years
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2 years
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p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Periodo de tiempo: 2 years
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2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- LCCC 0924
- P30CA016086 (Subvención/contrato del NIH de EE. UU.)
- CDR0000674103 (Otro identificador: PDQ number)
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. .
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