NCT03511859Unknown不适用
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics
CellMaxLife1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.
研究概览
简要总结
Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All subjects need to sign the informed consent form and age is above
- •Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI.
- •Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis
排除标准
- •Not willing to sign the informed consent form
- •Have been undergone general anesthesia or regional anesthesia in 1 month
- •Have been diagnosed with any type of cancer and been treated
- •Have been suffering from autoimmune disorder such as SLE and RA
- •Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia.
- •Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection
- •Diagnosed with myelodysplastic syndrome or myeloproliferative diseases
- •Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary
结局指标
主要结局
The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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