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Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends

23 de agosto de 2013 actualizado por: Cancer Research UK

The British Breast Cancer Study - National Cancer Research Network Cohort (BBC-NCRN)

RATIONALE: Studying samples of blood, urine, and tumor tissue in the laboratory from patients with cancer and their female relatives and friends may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at genes and other risk factors for second primary breast cancer in women with breast cancer and in their female family members and friends.

Descripción general del estudio

Descripción detallada

OBJECTIVES:

  • To identify new breast cancer susceptibility alleles in breast cancer patients and family controls.
  • To compare the prevalence of known polymorphisms in genes involved in hormonal activation and degradation pathways in breast cancer patients and family controls.
  • To correlate these polymorphisms with quantitative intermediate markers of susceptibility to breast cancer, such as circulating hormone levels and mammographic density.
  • To perform linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research.
  • To evaluate the relationship between these polymorphisms and hormone levels in relatives and family controls.
  • To compare average hormone levels in patients' unaffected first-degree relatives with family controls using urine samples from premenopausal women and urine and/or serum samples from postmenopausal women.
  • To perform follow-up in a cohort of unaffected first-degree relatives at moderate-to-high risk of developing breast cancer with prospective questionnaire data and hormone measurements.

OUTLINE: Unaffected and affected first-degree female relatives and family or friend controls undergo blood sample collection once during study. Genomic DNA is purified from the blood samples for genetic analyses. Within a cohort of unaffected first-degree relatives, postmenopausal women also provide a single urine sample for hormonal assays. Hormones analyzed in the serum and/or urine of postmenopausal women include estradiol, estrone, sulphate, prolactin, androstenedione, testosterone, progesterone, 17-hydroxyprogesterone, and SHBG. Unaffected premenopausal women within the cohort provide urine samples on 6 successive days around the midpoint of their menstrual cycle and on one day towards the luteal phase of their menstrual cycle. These samples are analyzed for luteinizing hormone and metabolites of estradiol and progesterone (i.e., creatinine ratios for estrone glucuronide and pregnanediol glucuronide).

Access to case notes, mammograms, and archival tumor blocks and accompanying pathology reports of breast cancer patients and their affected relatives is requested. When tumor samples from both tumors in bilateral cases are available, these samples are analyzed to identify regions of loss of heterozygosity in which both tumors have lost the same chromosomal region.

Cancer patients and controls, including affected or unaffected first-degree relatives, relatives by marriage, or friends complete a questionnaire at baseline to provide information on demographics (i.e., personal and family), cancer diagnosis and treatment (if applicable), and known risk factors for breast cancer (i.e., lifestyle, reproductive behavior, and family history).

Study participants may be followed periodically for cancer incidence and cause-specific mortality.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Tipo de estudio

De observación

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

    • England
      • London, England, Reino Unido, WC1E 7HT
        • Reclutamiento
        • London School of Hygiene and Tropical Medicine
        • Contacto:

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

No mayor que 70 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Women who have been diagnosed with contralateral or unilateral breast cancer
    • Family controls, including sisters and adult daughters of contralateral cases, female relatives by marriage
    • Unrelated controls (i.e., friends)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Pre- or postmenopausal

PRIOR CONCURRENT THERAPY:

  • Not specified

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?

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Prevalence of polymorphisms in candidate genes in contralateral patients and controls
Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls
Linkage analysis to detect new susceptibility genes in larger multiple-case families combined with data on families previously collected by the Institute of Cancer Research
Relationships between candidate gene polymorphisms and hormone levels in relatives and controls

Medidas de resultado secundarias

Medida de resultado
Average hormone levels in contralateral patients' first-degree relatives and controls

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Julian Peto, MD, London School of Hygiene and Tropical Medicine

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 2005

Finalización primaria (Anticipado)

1 de enero de 2009

Fechas de registro del estudio

Enviado por primera vez

9 de mayo de 2009

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2009

Publicado por primera vez (Estimar)

12 de mayo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de agosto de 2013

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

23 de agosto de 2013

Última verificación

1 de junio de 2009

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • CDR0000592728
  • CRUK-BBC-NCRN
  • UKCRN-1620
  • MREC--00/1/10
  • EU-20834

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

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