Treatment Response Prediction System of mCRC Patients Based on CTC
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 8, 2021
April 1, 2021
2.5 years
June 2, 2021
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity
The sensitivity of the response prediction model
1 year
Specificity
The specificity of the response prediction model
1 year
Study Arms (2)
Training Group
The training cohort that used to built the response prediction model
Validation Group
The validation cohort that used to validate the response prediction model
Interventions
Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)
Eligibility Criteria
Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy
You may qualify if:
- 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.
You may not qualify if:
- Other previous malignancy within 5 years
- Have metastases other than liver and lung metastases
- Receiving any treatment before first blood collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 8, 2021
Study Start
June 15, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2025
Last Updated
June 8, 2021
Record last verified: 2021-04