JRCT ID: jRCT1031210293
Registered date:04/09/2021
An Additional Analysis of Data from the PARADIGM Exploratory Study in Patients with Advanced/Recurrent Colorectal Cancer
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Colorectal cancer |
Date of first enrollment | 31/08/2021 |
Target sample size | 757 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | 1.Overall survival (OS) Time Frame: Up to approximately 63 months 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. 2.Progression-Free Survival (PFS) Time Frame: Up to approximately 63 months 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. |
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Secondary Outcome | 1.Evaluation of Correlation between Each Gene Mutations in Plasma Free DNA at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months 2.Evaluation of Correlation between Each Gene Expression Levels in Tumor Tissue at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months 3.Evaluation of Correlation between Change in Each Gene Mutations in Plasma Free DNA at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months 4.Evaluation of Correlation between Change in Each Gene Expression Levels in Tumor Tissue at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months 5.Evaluation of Correlation between High Gene Expression Region in Tumor Tissue at Baseline of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months 6.Evaluation of Correlation between Change in Gene Expression Region in Tumor Tissue at Baseline and Discontinuation of Protocol Treatment of Main Study, and Efficacy Endpoints (OS and PFS) Time Frame: Up to approximately 63 months |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 79age old |
Gender | Both |
Include 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. |
Exclude criteria | Participants who are considered inappropriate for participation in this study by the research institution |
Related Information
Primary Sponsor | Contact for Clinical Trial Information |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05030493 |
Contact
Public contact | |
Name | Trial Information Contact for Clinical |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-6-6204-2111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |
Scientific contact | |
Name | Trial Information Contact for Clinical |
Address | 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645 |
Telephone | +81-6-6204-2111 |
smb.Japanclinicalstudydisclosure@takeda.com | |
Affiliation | Takeda Pharmaceutical Company Limited |