Treatment Response Prediction System of mCRC Patients Based on CTC

NCT ID: NCT04917276

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2025-12-01

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.

Conditions

Colorectal Cancer Stage IV; Circulating Tumor Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Training Group

The training cohort that used to built the response prediction model

Circulating tumor cell

Intervention Type: DIAGNOSTIC_TEST

Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)

Validation Group

The validation cohort that used to validate the response prediction model

Circulating tumor cell

Intervention Type: DIAGNOSTIC_TEST

Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)

Interventions

Circulating tumor cell

Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jianmin Xu

Role: CONTACT

xujmin@aiiyun.com

+8613501984869

Other Identifiers

ZSCTC2

Identifier Type: -

Identifier Source: org_study_id