Treatment Response Prediction System of mCRC Patients Based on CTC
- Conditions
- Circulating Tumor CellColorectal Cancer Stage IV
- Interventions
- Diagnostic Test: Circulating tumor cell
- Registration Number
- NCT04917276
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age 18-80 years;
histologically proven colorectal liver metastasis
With liver-dominant disease (extrahepatic metastases limited to lung metastases)
ECOG 0-1
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.
- Other previous malignancy within 5 years
Have metastases other than liver and lung metastases
Receiving any treatment before first blood collection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Training Group Circulating tumor cell The training cohort that used to built the response prediction model Validation Group Circulating tumor cell The validation cohort that used to validate the response prediction model
- Primary Outcome Measures
Name Time Method Specificity 1 year The specificity of the response prediction model
Sensitivity 1 year The sensitivity of the response prediction model
- Secondary Outcome Measures
Name Time Method