CANCER MODELS FROM PEDIATRIC BRAIN AND SOLID CANCERS (CMDC)

根据该合同，该计划将支持生成约90个儿童ngcm，其中约20个来自脑肿瘤，包括弥漫性内在脑桥胶质瘤。预计现有的发展中国家最能满足这一需求，因为它们已为某些进程建立了基础设施。由于本项目生成的HCMI模型、材料和数据被视为“社区资源”，每个实验室必须确保交付的所有模型允许下游使用和分发不受阻碍。本合同的法规和技术要求如下：

Under this contract, the plan is to support the generation of ~90 pediatric NGCMs of which ~20 are from brain tumors including diffuse intrinsic pontine gliomas. It is expected that existing CMDCs are best poised to respond to this need as they have infrastructure in place for some of the process. Since the HCMI models, materials and data generated under this project are considered “Community Resources”, each laboratory has to ensure that all models delivered allow downstream use and distribution is unencumbered. The regulatory and technical requirements for this contract are listed below: 1. The models will require a sufficient aliquot of the “parent” tumor tissue for DNA and RNA sequencing (~2ug each) and DNA from normal case-matched sample, clinical data at the time of sample collection and at a minimum of 3 months’ follow-up once treatment (surgery, chemo- radiation- or other- therapies) has been initiated. This latter depends on the proposed pipeline and will be finalized when the CMDC is funded. 2. The list of the “general” clinical data is attached. In addition, a number of pediatric cancer specifics clinical report forms are already available (see https://ocg.cancer.gov/programs/hcmi/resources) and additional cancer-specific data elements would be agreed upon for new types of tumors once a contract is initiated. It is essential that all required clinical data elements as annotated in the CRFs (https://ocg.cancer.gov/programs/hcmi/resources) are collected. 3. The cancer models will be developed from tissue obtained under an IRB-approved human subjects’ protocol which informs the patient and their guardian about the project including the fact that these models: a. may be a “perpetual” resource, b. the tumor as well as normal tissue will be sequenced, c. clinical data will be collected, including outcome of treatment 3 months or longer after enrollment, d. the data sharing policy with data made available through controlled access at the NCI’s Genomic Data Commons, e. the models are distributed through a 3rd party, f. the patients will not benefit from participating, and g. results will not be shared with patients or their doctor.