CANCER MODELS FROM PEDIATRIC BRAIN AND SOLID CANCERS (CMDC)

根据该合同，该计划将支持产生约90个儿科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CMDC最有可能满足这一需求，因为它们已经为某些流程建立了基础设施。 由于HCMI模型、材料和本项目下生成的数据被视为“社区资源”，因此每个实验室必须确保交付的所有模型允许下游使用，并且分发不受阻碍。 本合同的法规和技术要求如下： 1. 这些模型将需要足够等份的“亲本”肿瘤组织用于DNA和RNA测序（各约2ug），以及来自正常病例匹配样品的DNA、样品收集时的临床数据和治疗（手术、化疗-放疗-或其他-治疗）开始后至少3个月的随访。 后者取决于拟议的管道，并将在CMDC获得资金时最终确定。 2. 随附“一般”临床数据列表。 此外，一些儿科癌症特异性临床报告表已经可用（见https：//ocg.cancer.gov/programs/hcmi/resources），一旦合同启动，将商定新类型肿瘤的额外癌症特异性数据元素。 收集CRF（https：//ocg.cancer.gov/programs/hcmi/resources）中注释的所有必需临床数据元素至关重要。 3. 癌症模型将根据IRB批准的人类受试者方案获得的组织开发，该方案告知患者及其监护人有关该项目的信息，包括这些模型的事实： a. 可以是“永久”资源， B. 将对肿瘤和正常组织进行测序， C. 将收集临床数据，包括入组后3个月或更长时间的治疗结局， D. 数据共享政策，通过NCI基因组数据共享区的受控访问提供数据， e. 模型通过第三方分发， F. 患者不会从参与中获益，并且 G. 结果不会与患者或其医生共享。

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.