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In March last year, the CCDI Molecular Characterization Initiative (MCI) launched. Since then, it has opened enrollment to children, adolescents, and young adults newly diagnosed with central nervous system tumors, soft tissue sarcomas, and rare tumors—with plans to expand. Results have been returned to more than 750 participants. Data released from the initiative are searchable through the database of Genotypes and Phenotypes and Seven Bridges’ Cancer Genomics Cloud. See Where Can These Data Be Accessed? on the MCI web page for more information about access. Enrollment continues and participation is free. Potential participants must also be receiving care from a […]

The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.  “Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who can’t provide consent for themselves and are afforded additional safeguards when participating in […]

Children, adolescents, and young adults (AYAs) with newly diagnosed rare tumors are now eligible to enroll in the CCDI Molecular Characterization Initiative. Rare tumors are childhood cancers that have a low number of patients, which have been hard to study and understand. Potential participants must also be receiving care from a Children’s Oncology Group-affiliated hospital. Enrollment is still also open to children and AYAs with central nervous system tumors and soft tissue sarcomas. The initiative will continue to expand to children and AYAs outside of Children’s Oncology Group–affiliated hospitals, those with other childhood cancers, and those whose cancer has returned. […]