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Clinical Trials/NCT04917276
NCT04917276
Not Yet Recruiting
N/A

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

Fudan University0 sites100 target enrollmentJune 15, 2021

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
December 1, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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