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临床试验/NCT02574546
NCT02574546撤回不适用

Molecular Markers for Predicting Risk of Developing Breast Cancer in Different Ethnicities

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Genetic changes in cells taken from the breasts of women undergoing mastectomy

研究概览

简要总结

This research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ in patients with different ethnic backgrounds.

详细描述

Evidence suggests that, besides reduced access to care, the increase in breast cancer incidence and mortality in AA (African American) compared to EA (European American or Caucasian) women is influenced by the biology of the tumor. Gene methylation changes caused by environmental factors starting at birth is one mechanism through which genetic and non-genetic factors could affect development of breast cancer and which could underlie disparities in aggressiveness. The investigators were the first to show that a panel of genes was hypermethylated specifically in AA-ER-negative tumors in young women in comparison to EA-tumors in women of the same age. Gene promoter methylation is found at low levels in healthy breast tissues from women without cancer. Race and family history of cancer increase the likelihood of these early events. Thus, epigenetic changes may be early events in transformation of breast cells and tumor formation.

This study will enroll women from different ethnic backgrounds undergoing mastectomy in order to collect normal and tumor tissue to study these genetic changes and breast cancer risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and older
  • Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE: Individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts.
  • ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2- or ER-, PR any, HER2+; "triple positive" breast cancers are not eligible).
  • Unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment).
  • Willing and able to sign an informed consent form

排除标准

  • 未提供

结局指标

主要结局

Genetic changes in cells taken from the breasts of women undergoing mastectomy

时间窗: Time of surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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