<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2021</study_start_year><data_sharing_plan>IPD Sharing (as of October 2023): Yes
Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda’s data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Additional information available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report</data_sharing_plan><condition>Colorectal Cancer</condition><condition>Colorectal Neoplasms</condition><disease>Colorectal Cancer</disease><disease>Colorectal Neoplasms</disease><study_type>Observational</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2388579</full_dataset_link><location>Japan</location><study_start_month>8</study_start_month><keyword>Panitumumab</keyword><keyword>Bevacizumab</keyword><repository>ECRIN MDR</repository><study_status>Recruiting</study_status></additional><is_claimable>false</is_claimable><name>An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal Cancer</name><description>The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer.
In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.</description><dates><creation>2021-08-15</creation></dates><accession>2388579</accession><cross_references><ClinicalTrials___gov>NCT05030493</ClinicalTrials___gov><Japan Registry of Clinical Trials>jRCT1031210293</Japan Registry of Clinical Trials><Japan Primary Registries Network>JPRN-jRCT1031210293</Japan Primary Registries Network></cross_references></HashMap>