The National Cancer Institute (NCI), part of the National Institutes of Health, Children’s Oncology Group(COG), and Nationwide Children’s Hospital are poised to change the direction of pediatric cancer diagnosis and care. New results from international efforts to characterize pediatric cancers have led to the Molecular Characterization Initiative: a project that aims to collect, analyze, and report clinical molecular data to support COG-affiliated clinicians in choosing the best treatment for each child. This program is part of the NCI Childhood Cancer Data Initiative (CCDI).
“These organizations have a shared vision: children with cancer receiving a precise diagnosis based on the molecular characteristics of their specific tumor. For each child, we hope to refine the initial diagnosis and potentially guide treatment,” notes Douglas S. Hawkins, MD, Group Chair of COG. “With more than 200 member hospitals that treat children with cancer, COG provides myriad opportunities for innovative life-saving research. It doesn’t matter where a family lives; if their child is diagnosed with cancer, they could have access to the Molecular Characterization Initiative.”
The CCDI Molecular Characterization Initiative currently is open only to children with newly diagnosed brain or spinal cord tumors. Later in 2022, the initiative will be expanded to include soft tissue sarcomas and a variety of rare pediatric cancers.
In addition to informed treatment options, the molecular data gleaned from this initiative will be added to NCI’s Cancer Research Data Commons, providing access to these data for cancer researchers worldwide.
Each organization has a key function in the CCDI Molecular Characterization Initiative:
- Initial enrollment in the CCDI Molecular Characterization Initiative is offered through “Project:EveryChild” (APEC14B1), a childhood cancer registry maintained by COG, as a grantee through an NCI-supported clinical trials group.
- Nationwide Children’s Hospital provides two critical aspects of the CCDI Molecular Characterization Initiative: the Biopathology Center, which oversees the COG Biobank, and the Steve and Cindy Rasmussen Institute for Genomic Medicine (IGM), which performs the clinical molecular characterization assays. The IGM is funded to perform these assays through a subcontract with Leidos Biomedical Research, Inc., current operator of the Frederick National Laboratory for Cancer Research.
- The Biopathology Center will receive tissues and bloods from patients enrolling onto the study and will prepare specimens for molecular analysis by extracting nucleic acids and performing quality control on these analytes. These will be forwarded to the IGM, where multiple clinical characterization assays of the tumor and blood analytes are conducted, the resulting data are analyzed and interpreted, and signed out as clinical results for return to the physicians who enroll patients onto the CCDI Molecular Characterization Initiative. These results will help refine the initial diagnosis, guide treatment decisions, and suggest potential clinical studies for that child. The IGM also will deposit data from these assays into NCI’s Cancer Research Data Commons.
Both the Biopathology Center and IGM Clinical Laboratory are accredited under the College of American Pathology Laboratory Accreditation Program and certified by CLIA (Clinical Laboratory Improvement Amendments) for clinical testing. The IGM Clinical Laboratory also is accredited by the New York State Department of Health, which is required for testing patients from New York State.
“Because these results impact patient care, extracted analytes from tumor tissue and blood must be shipped to the IGM within five days,” explains Nilsa Ramirez, MD, Director, Biopathology Center at Nationwide Children’s. “Time is of the essence when a child’s physician is waiting on results. We aim to complete the entire process from receiving the specimens at our center through final analysis in the IGM within 21 days, which is an exceptional turnaround time for this process. We’re proud to be an essential part of this pioneering initiative.”
“Executing multiple genomic tests to produce data that are interpreted through rapid and scalable computational analyses and lead to medically relevant results requires a highly integrated clinical environment,” says Elaine R. Mardis, PhD, IGM Co-Executive Director and principal investigator of the MCI contract. “We are excited to be part of this incredibly worthy endeavor.”
The first completed results were provided on April 14, 2022, for a participant enrolled on March 25, 2022. As many as 3,000 participants are expected each year.
“The CCDI Molecular Characterization Initiative is a transformative collaboration,” says Richard Wilson, PhD, IGM Executive Director. “We anticipate this project will fundamentally transform how we diagnose and treat children facing cancer.”
