NCT02712645Unknown不适用
A Multicenter Breast Cancer Biospecimen Registry
Luminist, Inc.0 个研究点目标入组 700 人开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 主要终点
- Number of patients with untreated newly diagnosed breast cancer.
研究概览
简要总结
This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of all racial and ethnic groups who are 40 years or older.
- •Women must:
- •have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
- •be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.
排除标准
- •Inability to sign informed consent.
- •More than one radiological finding.
- •Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
- •Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
- •Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
- •Received any experimental therapeutic treatment during the previous 3 months.
- •Received any blood product transfusion within the previous 3 months.
- •Use of illegal drugs during the previous 3 months.
- •Pregnant or nursing at the time of enrollment or in the preceding 12 months.
结局指标
主要结局
Number of patients with untreated newly diagnosed breast cancer.
时间窗: 1 Year
次要结局
未报告次要终点
研究者
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