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
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Cancer Stage IV
• Colorectal Neoplasms
• Neoplastic Cells, Circulating

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