Children's Oncology Group Statistics and Data Center

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CIBMTR Linkage COG sites submit clinical data about transplants to the Center for International Blood & Marrow Transplant Research (CIBMTR). It would be beneficial for COG to have access to the wealth of patient-level clinical transplant data obtained by the CIBMTR. ComboMATCH ComboMATCH will be one of the successor trials to MATCH which will focus on drug combinations. COG will develop a cassette of treatment sub-studies for pediatric and young adult patients. Harmonization and transfer of data to the Pediatric Cancer Data Commons International pediatric cancer data commons (PCDC) consortiums have been developed for several disease areas. COG statisticians will harmonize data from completed COG trials to align with the data dictionaries and then transfer the data to the PCDC. Molecular Characterization Protocol The NCI is sponsoring program of centralized molecular characterization for pediatric patients with brain tumors, soft tissue sarcomas, and selected rare cancers, using Project: EveryChild (APEC14B1) as the mechanism for enrollment, specimen collection, and clinical annotation. Molecular Characterization MCI Reporting The Molecular Characterization Initiative (MCI) provides state-of-the-art molecular characterization at the time of diagnosis that helps participants and doctors select the best and most appropriate treatment. Project: EveryChild (APEC14B1) is used as the mechanism for enrollment, specimen collection, and clinical annotation. MCI data collected via APEC14B1 will be transferred to the NCI for reporting purposes. Other Operational Needs Funds are requested to assist with expenses for Medidata RAVE academic professional support, Statistical Software, and Supplies for Teleworking Optimization. Phase III NCNT/NCORP Data Archive Data from phase 2 and 3 studies completed by COG are available to researchers outside of COG through the NCTN/NCORP Data Archive. In this grant year data will be submitted to the NCTN/NCORP Data Archive for manuscripts summarizing results several studies. Project EveryChild (PEC) Build Optimization The data collected on Project:EveryChild will be a major source of data for the National Cancer Institute’s (NCI) Childhood Cancer Data Initiative (CCDI) Global Data Commons. COG has developed a parent/child study builds plan which would allow for flexibility in form changes and minimization of the impact of smaller focused child study migrations, greatly reducing the workload and url resources required for disease specific requested changes. RAVE Global Library COG in partnership with Westat has developed processes and procedures to catalogue and standardize the clinical data within and across COG studies, by disease area, in preparation for loading into the CCDI Global Data Commons. The standardized data collection will become the basis for a global library of eCRFs in Medidata Rave which will ensure the usage of the standards and improve efficiencies in study build and analysis. Tumor Specimens from Patients at Relapse COG solid tumor committees have a desire to increase biospecimen banking of tumor tissue obtained at relapse, with clinical annotation for future research. Funding will be used to enhance the volume and quality of tumor specimens obtained at relapse, as well as improve the characterization, stability, and utility of already banked biospecimens.