- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00896818
Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Contactos e Locais
Locais de estudo
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England
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London, England, Reino Unido, WC1E 7HT
- Recrutamento
- London School of Hygiene and Tropical Medicine
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Contato:
- Julian Peto, MD
- Número de telefone: 44-20-7927-2632
- E-mail: julian.peto@lshtm.ac.uk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Prevalence of polymorphisms in candidate genes in contralateral patients and controls
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Prevalence of alleles in breast cancer patients from multiple-case families and those in blood-unrelated family controls
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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
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Relationships between candidate gene polymorphisms and hormone levels in relatives and controls
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Medidas de resultados secundários
Medida de resultado |
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Average hormone levels in contralateral patients' first-degree relatives and controls
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julian Peto, MD, London School of Hygiene and Tropical Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDR0000592728
- CRUK-BBC-NCRN
- UKCRN-1620
- MREC--00/1/10
- EU-20834
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