CHILDHOOD CANCER DATA INITIATIVE: CLINICAL TRIAL SPECIMEN MOLECULAR CHARACTERIZATION (CTSMC) PROGRAM

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The National Cancer Institute (NCI) Childhood Cancer Data Initiative (CCDI) focuses on the critical need to collect, analyze, and share data to address the burden of cancer in children, adolescents, and young adults (AYAs). The initiative supports childhood cancer research and aims to make it easier for researchers to learn from each of the approximately 16,000 children and adolescents diagnosed with cancer in the United States each year. Through the CCDI, NCI seeks to enhance data collection for childhood cancers, ensure that data is accessible, and thereby incentivize the cancer research community to develop new treatments for children with cancer. More specifically, to increase data use and sharing in pursuit of progress against childhood cancers, the CCDI aims to: • Maximize every opportunity to improve treatments and outcomes for children with cancer • Build a connected data infrastructure to enable sharing of childhood cancer data from multiple sources • Identify opportunities to make data work better for patients, clinicians, and researchers • Develop and enhance tools and methods to extract knowledge from data Cancer clinical trials are available for children and AYAs through the NCI-funded Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Children’s Oncology Group (COG). Through these clinical trials, pediatric and AYA cancer patients across the U.S. and around the world can access state-of-the-art therapies, and specimens are routinely collected from patients enrolled across these clinical trials. Other NCI-supported studies collect patient data and specimens from pediatric and AYA cancer patients to better understand these diseases and find potential treatments. Tissue samples from children and AYAs with cancer are critically limited and a valuable resource. Data generated from these specimens are often fragmented and not broadly available to researchers and oncology teams. Next-generation sequencing technologies are increasingly available to quickly sequence DNA and RNA and identify gene mutations, genetic alterations, and changes in global gene expression that are associated with different tumor types and stages of disease. Other complementary technologies for molecular characterization, such as assays for metabolomics, epigenomics, and proteomics as well as more established IHC or FISH assays, are also now accessible. Att. 1, 75N91019D00024, Task Order 75N91020F00021, through modification 6. 04/13/2023 Pg 3 Maximizing the use of childhood and AYA cancer specimens collected on NCI-supported clinical trials and studies and making the resulting data broadly available for research will have a profound impact on our ability to prevent, diagnose, and treat this patient population, and can serve as a model for improving the use of data across cancer types and other disease continuums.