Treatment Response Prediction System of mCRC Patients Based on CTC

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Circulating Tumor Cell; Colorectal Cancer Stage IV
• Intervention / Treatment: Diagnostic test: Circulating tumor cell

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jianmin Xu; Phone Number: +8613501984869; Email: xujmin@aiiyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training Group; The training cohort that used to built the response prediction model	Diagnostic test: Circulating tumor cell; 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	Diagnostic test: Circulating tumor cell; Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of the response prediction model	1 year
Specificity	The specificity of the response prediction model	1 year

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasm Metastasis; Colorectal Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: ZSCTC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No