NCT04917276
Not Yet Recruiting
N/A
Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer Stage IV
- Sponsor
- Fudan University
- Enrollment
- 100
- Primary Endpoint
- Specificity
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Other previous malignancy within 5 years
- •Have metastases other than liver and lung metastases
- •Receiving any treatment before first blood collection
Outcomes
Primary Outcomes
Specificity
Time Frame: 1 year
The specificity of the response prediction model
Sensitivity
Time Frame: 1 year
The sensitivity of the response prediction model
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