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临床试验/NCT04917276
NCT04917276尚未招募不适用

Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells

Fudan University0 个研究点目标入组 100 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Specificity

研究概览

简要总结

This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years;
  • histologically proven colorectal liver metastasis
  • With liver-dominant disease (extrahepatic metastases limited to lung metastases)
  • A life expectancy of ≥ 3 months
  • Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3
  • Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl
  • Written informed consent for participation in the trial.

排除标准

  • Other previous malignancy within 5 years
  • Have metastases other than liver and lung metastases
  • Receiving any treatment before first blood collection

结局指标

主要结局

Specificity

时间窗: 1 year

The specificity of the response prediction model

Sensitivity

时间窗: 1 year

The sensitivity of the response prediction model

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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