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Guest Blog–Conversations on Cancer – Pediatric Cancers: Navigating the Challenges Together

November 19, 2024
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In conjunction with the European Medicines Agency (EMA), the FDA Oncology Center of Excellence (OCE) held a one-hour Conversations on Cancer public panel discussion on November 19, 2024, to examine an array of challenging decisions faced by members of the pediatric oncology community. The panel discussion featured current CAC2 Board Member Nicole Scobie (Zoe4Life) and past CAC2 Board Member Donna Ludwinski (Solving Kids' Cancer). Because of the rarity of cancers arising in childhood and adolescence and high unmet medical need, pediatric oncology drug development is inherently complex. As a result, pediatric oncology clinician investigators are faced with challenges related to [...] Read more

Guest Blog–Molecular Characterization Initiative (MCI) Continues to Enroll

March 6, 2023
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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 […]

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Save the Date! Action Days 2023 Returns to Washington, D.C.

December 8, 2022
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By Guest Blogger Sarah Milberg, Co-Chair of the Alliance for Childhood Cancer and Director of Government Relations and Advocacy for the St. Baldrick’s Foundation Thanks to advocates like you, we have been able to make great progress on important childhood cancer issues before Congress. The Alliance for Childhood Cancer is excited to announce that Action Days 2023 will return back to Washington, D.C. from April 24-25, 2023. Registration will open in early 2023. Action Days gives you an opportunity to speak with your members of Congress and their staff to advocate for important childhood cancer issues before Congress. Sharing your story next […]

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Guest Blog–The Fit for Filing Group at ACCELERATE

November 14, 2022
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Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group   The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies.   The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are: Define the barriers and propose solutions to ensure […]

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Guest Blog–New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

November 5, 2022
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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 […]

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Guest Blog–National Cancer Institute’s CCDI Molecular Characterization Initiative Adds Rare Tumors

September 12, 2022
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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. […]

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Guest Blog–National Cancer Institute Launches the CCDI Molecular Targets Platform

August 10, 2022
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The Molecular Targets Platform is an NCI-supported instance of the  Open Targets Platform with a focus on preclinical pediatric oncology data. It is a tool that supports the identification and prioritization of molecular targets expressed in childhood cancers.   The Molecular Targets Platform builds upon the data and functionality of the Open Targets Platform while also including: The FDA Pediatric Molecular Target Lists (FDA PMTL) Analyses of pediatric oncology datasets from the Open Pediatric Cancer (OpenPedCan) project at the Children’s Hospital of Philadelphia: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Open Pediatric Brain Tumor Atlas (OpenPBTA) Gabriella Miller Kids […]

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Guest Blog–National Cancer Institute Expands Molecular Characterization Initiative for Childhood Cancer Research

June 29, 2022
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The National Cancer Institute’s new Molecular Characterization Initiative (MCI) fosters data sharing in childhood cancer research. The program is expanding comprehensive molecular characterization of tumors to children, adolescents, and young adults (AYAs) with newly diagnosed soft tissue sarcomas receiving care at hospitals affiliated with the Children’s Oncology Group. The DNA and RNA in participants’ tumors are analyzed through this voluntary, free program.  This effort is in addition to the previous cohort that targeted the molecular characterization of newly diagnosed central nervous system tumors in children and AYA patients.   Participants’ tumor and blood samples are analyzed in an accredited lab, with […]

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Guest Blog–National Cancer Institute Launches Molecular Characterization Initiative for Childhood Cancer Research

March 23, 2022
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The National Cancer Institute’s new Molecular Characterization Initiative (MCI) fosters data sharing in childhood cancer research. The program currently offers comprehensive molecular characterization of tumors to children, adolescents, and young adults (AYAs) with newly diagnosed central nervous system tumors receiving care at hospitals affiliated with the Children’s Oncology Group. The DNA and RNA in participants’ tumors are analyzed through this voluntary, free program.    Participants’ tumor and blood samples are analyzed in an accredited lab, with results shared with families and doctors within 21 days. This detailed information about the cancer can be used to make a more precise diagnosis, […]

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CAC2 Member Blog–Delayed Diagnosis for Children with Cancer

July 29, 2021
Blog Posts, Guest Blogs, Member Blogs 1 comment
By CAC2 Member Susan Guisto (Friends of Cathryn Foundation) and Guest Blogger Judith G. Villablance, MD, Children's Hospital Los Angeles Every year, approximately 1 in 10,500 children from birth to 15 years of age are diagnosed with cancer in the United States. Most pediatricians will likely encounter only one to three cases throughout their professional lifetime. Even though a pediatrician may never see a case of cancer in his or her practice, it is important to understand what to look for, how to evaluate patients and to ensure follow-up and timely referrals to specialists. As a result, pediatricians can play [...] Read more
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