(COLUMBUS, Ohio) – The CCDI Molecular Characterization Initiative (MCI) is a project that aims to collect, analyze and report clinical and molecular data and is currently supporting Children’s Oncology Group (COG)-affiliated clinicians in choosing the best treatment for each child through precision diagnosis. This program is part of the National Cancer Institute (NCI) Childhood Cancer Data Initiative (CCDI), a national commitment and community-wide effort to harness data in ways that speed up progress in childhood cancer. Announced last year, the MCI is a collaboration among NCI, part of the National Institutes of Health, COG and Nationwide Children’s Hospital and is the largest initiative of its kind in the United States.
“Just one year in, we are tremendously proud of the number of cancer patients we have supported through molecular characterization,” said Elaine Mardis, PhD, co-executive director of the Steve and Cindy Rasmussen Institute for Genomic Medicine (IGM) at Nationwide Children’s. “This initiative increases the accessibility to state-of-the-art clinical genomic testing for pediatric cancer patients across the United States and around the world.”
The MCI enrolled their first patient March 31, 2022. Since then, samples from 1,236 patients have been received at the COG Biobank housed at the Nationwide Children’s Biopathology Center, where they are processed to extract DNA and RNA and sent on to Nationwide Children’s IGM for testing. Out of these samples, 1,137 were of sufficient quality and quantity for molecular analysis by the IGM. The IGM is funded to perform this analysis through a subcontract with Leidos Biomedical Research, Inc., current operator of the Frederick National Laboratory for Cancer Research.
To date, the team has received samples from children in 47 states. They’ve also received more than 120 international samples from Australia, Canada and New Zealand. In total, 166 of 226 COG sites have enrolled patients onto the MCI.
“At Nationwide Children’s, we are deeply invested in promoting health equity for children everywhere,” said Dr. Mardis. “For the children represented by these samples, we are bringing precision diagnosis to them where they are receiving care. This increase of access supports clinicians and families across the country and international COG sites, and it is a wonderful example of how our efforts contribute to health equity.”
While the MCI initially focused on pediatric brain and spinal cord cancers, the types of tumors sampled and tested have expanded to include soft tissue sarcomas and a subset of other rare cancers.
“At the Biopathology Center, we oversee the COG Biobank and this work for the MCI has been a wonderful example of our mission. We ensure that patient samples are processed to providehigh-quality specimens for molecular analysis and biobanking,” said Nilsa Ramirez, MD, director for the Biopathology Center in the Abigail Wexner Research Institute at Nationwide Children’s.
For MCI testing, the IGM team sequences tumor and normal DNA to identify alterations, sequences the RNA using a fixed panel to identify fusions and performs microarray-based DNA methylation. All testing results are delivered to providers as clinical results for use in medical care decisions.
“With these results impacting patient care, time is of the essence. We aim to complete the entire process from receipt of 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,” said Dr. Ramirez.
The returned results are provided to clinicians and participants through state-of-the-art cloud-based access to clinical reports. The genomic data and clinical results from testing are accessible to researchers through the CCDI Data Ecosystem, run by the NCI to enable future research in pediatric cancers. Data from over 800 cases already are available in the CCDI Data Ecosystem.
With over 220 COG member hospitals that treat childhood cancer, the initiative is poised for continued growth.
“It has been amazing to see the vision of these organizations come together to transform the MCI from idea to reality,” said Douglas Hawkins, MD, group chair of COG. “For 92.5% of the samples analyzed to provide cancer-relevant data for clinical decision making is so exciting. And we’re just getting started. As the types of tumors being analyzed expands and as the field of molecular characterization continues to evolve, we look forward to being able to offer valuable information for clinicians and researchers.”
|
Returning Clinically Relevant Results |
|
|
Testing methodology |
Percent with clinically reportable results |
|
Tumor/normal comparison |
84% |
|
Methylation (brain tumor samples only) |
79% |
|
Fusion testing |
28% |
|
OVERALL |
92.5% |
About The Children’s Oncology Group (COG)
COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 17,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.
About Nationwide Children's Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2021-22 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit free-standing pediatric health care systems providing unique expertise in pediatric population health, behavioral health, genomics and health equity as the next frontiers in pediatric medicine, leading to best outcomes for the health of the whole child. Integrated clinical and research programs are part of what allows Nationwide Children’s to advance its unique model of care. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the US, supporting basic, clinical, translational, behavioral and population health research. The AWRI is comprised of multidisciplinary Centers of Emphasis paired with advanced infrastructure supporting capabilities such as technology commercialization; gene- and cell-based therapies; and genome sequencing and analysis. More information is available at NationwideChildrens.org/Research.