Treatment Response Prediction System of mCRC Patients Based on CTC

Fudan University

Status: Not yet enrolling

Conditions: Colorectal Cancer Stage IV; Circulating Tumor Cell

Treatments: Diagnostic Test: Circulating tumor cell

Study type: Observational

Funder types: Other

Identifiers

NCT04917276

ZSCTC2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Training Group

Description:

The training cohort that used to built the response prediction model

Treatment:

Diagnostic Test: Circulating tumor cell

Validation Group

Description:

The validation cohort that used to validate the response prediction model

Treatment:

Diagnostic Test: Circulating tumor cell