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NCT04917276 Clinical Trial

Treatment Response Prediction System of mCRC Patients Based on CTC

Circulating Tumor Cell Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04917276
Other study ID # ZSCTC2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date December 1, 2025

Study information
Verified date April 2021
Source Fudan University
Contact Jianmin Xu
Phone +8613501984869
Email xujmin@aiiyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2025
Est. primary completion date December 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Other previous malignancy within 5 years Have metastases other than liver and lung metastases Receiving any treatment before first blood collection

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Circulating tumor cell
Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity The sensitivity of the response prediction model 1 year
Primary Specificity The specificity of the response prediction model 1 year
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