September 21, 2023
National Cancer Institute (NCI)
The National Cancer Institute (NCI) is seeking broad input from persons and entities with interest, expertise, and experience in the conduct of research of cancer in children, adolescents, and young adults (AYA), in line with the overarching goals and objectives of the Childhood Cancer Data Initiative (CCDI). The NCI is seeking this input to help inform future resource allocation and acquisition strategies to accelerate scientific discovery for improving patient care through enhanced data sharing. Input is requested that will help identify opportunities for the generation of multiple omics research data on pediatric cancer samples that will address unmet scientific and clinical needs aligned with the CCDI research priorities.
The NCI’s Childhood Cancer Data Initiative (CCDI) focuses on the critical need to collect, share access and analyze data to address the burden of cancer in children, adolescents, and young adults (AYAs). The data initiative supports childhood cancer research and aims to provide cancer researchers with additional capabilities to learn from each of the approximately 16,000 children and AYA’s diagnosed with cancer in the United States each year.
The CCDI foundational goals are to:
The CCDI aims to strengthen data generation and collection for childhood cancers, to foster data utilization and sharing to advance progress in combating these cancers, to ensure that Findability, Accessibility, Interoperability, and Reusability (FAIR) Principles are upheld, and to incentivize the cancer research community to develop new treatments for children with cancer. The generation of molecular data on children and AYA patients enrolled in clinical trials is extremely valuable to realizing the promise of precision oncology. High quality specimens routinely collected from patients enrolled in clinical trials and other studies present opportunities for molecular subtyping to aid in clinical decision-making, as well as complementary research efforts to further the understanding of disease biology. Such cohorts and samples, however, are critically limited for pediatric and AYA cancer, posing critical challenges to paint a comprehensive molecular profile of a patient. Furthermore, data that were generated from these specimens in the past are often not broadly available to researchers for secondary use.
CCDI has a unique opportunity to both prospectively generate and retrospectively aggregate many sources of data to enhance data use for the broad research community. For example, the CCDI Molecular Characterization Initiative (MCI) has built an effective clinical molecular characterization pipeline to accomplish the CCDI mission by generating and sharing Clinical Laboratory Improvement Amendments (CLIA)-certified sequencing data through the CCDI Data Ecosystem using specimens from pediatric and AYA patients enrolled through Children’s Oncology Group’s Project: EveryChild. Remaining specimens from MCI or other sample sources, whenever available, present an unprecedented opportunity for additional research molecular characterization (non-CLIA) including transcriptomics, proteomics, and metabolomics to complement clinical sequencing data. Research on molecular characterization using multi-omics approaches can provide a more unified, and comprehensive view of the underlying disease in order improve the treatment, survival, and quality of life of every patient. By establishing a pipeline for clinical and research molecular characterization, and making the data broadly available, CCDI will maximize the impact of the contributions of study participants on our ability to prevent, diagnose, and treat this patient population. This effort can serve as a model for enhancing the use of data across the pediatric and AYA cancer continuums.
All stakeholders with an interest, expertise and experience in childhood and AYA cancer research are invited to provide information. Every response should mention respondent's membership or affiliation within industry, government, or academia.
NCI is seeking information that includes, but is not limited to, perspectives on the following areas:
Through this Request for Information (RFI) notice, the NCI invites participation from stakeholders across the childhood cancer research enterprise: individual researchers, pediatric oncologists, patients and their families, clinical trial cooperative groups, data scientists, advocacy groups, foundations, etc. All participants are encouraged to respond to as many questions as they are able, no matter their roles in the research enterprise. All comments must be submitted electronically by clicking on this link: Request for Information: Identifying Opportunities to Generate Research Molecular Characterization Data for the Childhood Cancer Data Initiative (CCDI) by 11:59:59 pm (ET) November 30 , 2023. Names need not be associated with responses; responses are voluntary and may be submitted anonymously. Responders are free to address any or all the questions. Please consider forwarding the link to others within or outside your institution whose perspectives you feel we should hear.
This RFI is for planning purposes only and should not be construed as a solicitation or an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The NIH does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the Government’s use of such information.
Responses to this RFI are voluntary. Proprietary, classified, confidential, or sensitive information should not be included in your response. NCI will use the information submitted in response to this RFI at its discretion and will not provide comments to any individual respondent's submission. Any identifiers (e.g., names, institutions, e-mail addresses, etc.) will be removed when responses are compiled. The information provided will be analyzed and may be shared publicly or appear in reports, public NIH websites, or in the development of future funding opportunities. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
The NCI looks forward to your input, and we hope that you will share this RFI document with your colleagues for their input.
Emily Boja, Ph.D.
Office of Data Sharing
National Cancer Institute (NCI)