Tear Based Sample Collection for Breast Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participant tear samples collected.
研究概览
简要总结
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
详细描述
Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individual is an adult woman and has recently been diagnosed with breast cancer.
排除标准
- •Individual is excluded if they have already started treatment for the breast cancer diagnosis.
- •Age less than 18 or more than 100 years.
结局指标
主要结局
Number of participant tear samples collected.
时间窗: 90 days
The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.
次要结局
未报告次要终点