NCT03372902已完成不适用
MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 7
- 主要终点
- number of participants with malignant biopsy
研究概览
简要总结
The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.
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
- 否
入选标准
- •Females with one or more BI-RADS 4 radiographic lesions who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at MSKCC or at an MSK Alliance Member Site. If multiple imaging modalities were employed (mammogram, ultrasound, MRI) and no integrated score is provided, then the highest BI-RADS score will be used.
- •Age ≥ 18 years at the time of breast biopsy
- •Willing to provide blood samples for research purposes before biopsy.
- •Able to provide written informed consent
排除标准
- •Women with a BI-RADS 4 lesion who had the lesion previously biopsied
- •Females with a current active malignancy other than non-melanoma skin cancers. Females are considered not to have a "current active" malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis
- •Currently pregnant women
- •History of bilateral mastectomy.
- •Participant has or is currently participating in another GRAIL-sponsored protocol
结局指标
主要结局
number of participants with malignant biopsy
时间窗: 2 years
result of the biopsy of the BIRADS 4 breast
次要结局
未报告次要终点
研究者
研究点 (7)
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