NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedColorectal cancer
Date of first enrollment31/08/2021
Target sample size757
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary Outcome1.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.
Secondary Outcome1.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
Age maximum<= 79age old
GenderBoth
Include criteria1.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 criteriaParticipants who are considered inappropriate for participation in this study by the research institution

Related Information

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
E-mail 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
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited