Gene Methylation and Estradiol Levels in Random FNA Samples as Biomarkers for Breast Cancer Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate
研究概览
简要总结
RATIONALE: Studying samples of blood and breast tissue from healthy women in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to breast cancer risk.
PURPOSE: This research study is looking at breast tissue in women not previously diagnosed with breast cancer who are undergoing fine-needle aspiration.
详细描述
OBJECTIVES:
Primary
- To determine if breast tissue DNA methylation profile and hormone concentration change across follicular and luteal phase, or across menopause, in random fine needle aspiration samples of women with no prior diagnosis or treatment for breast cancer.
- To determine if DNA methylation profile and breast hormone levels correlate with mammographic density, cytomorphology, or Gail risk estimates.
- To develop a high throughput commercial assay for DNA methylation profiling for assessing breast cancer risk.
- To develop a highly sensitive, specific, and novel nanoassay for estradiol and progesterone.
OUTLINE: This is a multicenter study.
Premenopausal women are stratified by menstrual cycle phase (mid-follicular [day 5-10] vs mid-luteal [day 20-25]), based on an adjusted 28-day cycle.
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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between DNA methylation profiles and mammographic density, cytomorphology, or Gail risk estimate
时间窗: One time rFNA procedure to collect sample to compare with baseline mammogram and risk info.
Differences in DNA methylation profiles between women in different menstrual stages
时间窗: One time rFNA procedure to collect samples
次要结局
未报告次要终点