An Additional Analysis of Data from the PARADIGM Exploratory Study in Patients with Advanced/Recurrent Colorectal Cancer
Not Applicable
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-jRCT1031210293
- Lead Sponsor
- Contact for Clinical Trial Information
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 757
Inclusion Criteria
1.Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
2.Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.
Exclusion Criteria
Participants who are considered inappropriate for participation in this study by the research institution
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Overall survival (OS)<br>Time Frame: Up to approximately 63 months<br>OS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene expression. OS will be measured as the time from the date of randomization to the date of death due to any causes.<br><br>2.Progression-Free Survival (PFS)<br>Time Frame: Up to approximately 63 months<br>PFS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between the PFS and gene expression. PFS is defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.
- Secondary Outcome Measures
Name Time Method