The National Cancer Institute (NCI) recently announced the launch of its Molecular Characterization Initiative for pediatric tumors. This program will provide biomarker testing free of charge to children, adolescents, and young adults with newly diagnosed CNS tumors who are receiving treatment at Children's Oncology Group (COG)–affiliated hospitals. The COG-affiliated hospitals include more than 200 hospitals and institutions that treat most children diagnosed with cancer in the United States. The Molecular Characterization Initiative is available through NCI's Childhood Cancer Data Initiative, which was launched in 2019 to promote data sharing and collection of new data among researchers who study childhood cancers.

Results of tumor and blood DNA and RNA analyses will assist clinicians in making an accurate diagnosis and in deciding the best possible treatment plans, including whether a child is eligible for a clinical trial. Enrollment in the Molecular Characterization Initiative is initially offered through participation in Project: Every Child, a childhood cancer registry maintained by COG. Initial participants will include newly diagnosed children, adolescents, and young adults aged 25 years and younger at the time of diagnosis. Young adults over age 25 years who are being screened for eligibility into a COG clinical trial may also be included.

The Molecular Characterization Initiative will expand to include children, adolescents, and young adults with soft tissue sarcomas and other rare tumors later in 2022. In late 2022 and 2023, it will continue to expand to children, adolescents, and young adults outside of COG-affiliated hospitals, those with other childhood cancers, and those whose cancer has returned.

In the press release, Brigitte C. Widemann, MD, special advisor to the NCI director for childhood cancer, stated, "The ultimate dream has really been for every child with cancer to have a state-of-the-art diagnosis and the safest and most effective therapy. The Molecular Characterization Initiative is a transformative collaboration that will entail participation of the entire community."

According to the press release, this new program will make tumor molecular characterization extensively available for children across the U.S. In addition, data collected through the program will be stored in a central location for researchers to help them better understand the molecular causes of childhood cancers and to develop more effective and possibly fewer toxic therapies.

Douglas S. Hawkins, MD, group chair of COG, stated, "The game changer for patients is that we're going to understand the patient's disease precisely and comprehensively in a way that we've done piecemeal so far."

"We can help make molecular characterization available throughout the country so that it will be a standard of care that every child can get," stated Maryam Fouladi, MD, COG central nervous system tumor disease committee leader. "An accurate molecular diagnosis can inform optimal treatment for every child."

Dr. Fouladi also explained that some childhood cancers, such as gliomas, can be misdiagnosed and stated, "We can apply molecular diagnostics to a child diagnosed with a high-grade glioma and find out that it is actually a low-grade glioma or an entirely different tumor, which may need very different treatments and have a very different outcome. Molecular diagnostics can really contribute to getting the correct diagnosis, offering the optimal treatment and, ultimately, improving the patient's outcome."

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