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Biomarkers in Blood Samples From Older Breast Cancer Survivors

26 de febrero de 2014 actualizado por: UNC Lineberger Comprehensive Cancer Center

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

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

De observación

Inscripción (Actual)

246

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Breast cancer survivors age 50 and older who have completed their breast cancer treatment.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
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
Treatment w/endocrine therapy
Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.
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
Treatment w/ chemotherapy
Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy.
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
p16INK4a expression between cohort 2 vs cohort 3
Periodo de tiempo: 2 years
2 years
p16INK4a expression between cohort 1 vs cohort 2
Periodo de tiempo: 2 years
2 years
p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Periodo de tiempo: 2 years
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2010

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de febrero de 2014

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2010

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2010

Publicado por primera vez (Estimar)

7 de junio de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

26 de febrero de 2014

Última verificación

1 de febrero de 2014

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre Cáncer de mama

Ensayos clínicos sobre gene expression analysis

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