CANCER MODELS FROM PEDIATRIC BRAIN AND SOLID CANCERS (CMDC)

根据这份合同，该计划将支持产生~90个儿科NGCM，其中~20个来自脑肿瘤，包括弥漫性桥脑胶质瘤。预计现有的中央管理和发展中心最有能力满足这一需求，因为它们已为某些进程建立了基础设施。由于在该项目下产生的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所示： 1.这些模型将需要足够的“亲本”肿瘤组织用于DNA和RNA测序(每个~2ug)和来自正常病例匹配样本的DNA、样本收集时的临床数据以及治疗(手术、化疗-放射-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获得资金时最后敲定。 2.附“一般”临床资料一览表。此外，一些儿科癌症特定临床报告表已经可用(参见https://ocg.cancer.gov/programs/hcmi/resources)和其他癌症特定数据元素)，一旦合同启动，将就新类型的肿瘤商定其他癌症特定数据元素。收集CRFS(https://ocg.cancer.gov/programs/hcmi/resources)中注释的所有必需的临床数据元素是至关重要的。 3.癌症模型将从IRB批准的人类受试者方案下获得的组织中开发，该方案将向患者及其监护人通报该项目，包括以下事实： A.可能是一种“永久”资源， B.肿瘤和正常组织都将被测序， C.将收集临床数据，包括登记后3个月或更长时间的治疗结果， D.与NCI基因组数据共享中心通过受控访问提供的数据共享政策； E.模型通过第三方分发， F.患者将不会从参与中受益，以及 结果不会与患者或他们的医生分享。

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.