国家癌症研究所篮子/伞式临床试验：MATCH、LungMAP 及其他。
National Cancer Institute Basket/Umbrella Clinical Trials: MATCH, LungMAP, and Beyond.
机构信息
From the Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis.
Division of Cancer Biology.
出版信息
Cancer J. 2019 Jul/Aug;25(4):272-281. doi: 10.1097/PPO.0000000000000389.
Abstract
With advances in genetic testing and its common usage, the field of precision medicine has exploded in the field of oncology. The National Cancer Institute is uniquely positioned to lead in this area of research through its wide network of investigators, partnerships with pharmaceutical companies in drug development, and laboratory capabilities. It has developed a portfolio of trials as part of a Precision Medicine Initiative that uses various basket/umbrella designs to increase the understanding of treatment of cancer through genetic selection and targeted therapies. This article describes these trials, ALCHEMIST, LungMAP, NCI/NRG ALK Trial, MPACT, NCI-MATCH, and pediatric MATCH, and their contributions to the area of precision medicine.
摘要
随着基因检测技术的进步及其广泛应用，精准医学领域在肿瘤学领域得到了迅猛发展。美国国家癌症研究所（National Cancer Institute，NCI）通过其广泛的研究人员网络、与制药公司在药物开发方面的合作以及实验室能力，在这一研究领域处于领先地位。该机构已开发出一系列临床试验，作为精准医学计划（Precision Medicine Initiative）的一部分，这些试验采用各种篮子/伞式设计，通过基因选择和靶向治疗来增加对癌症治疗的了解。本文描述了这些临床试验，即 ALCHEMIST、LungMAP、NCI/NRG ALK 试验、MPACT、NCI-MATCH 和儿科 MATCH，以及它们对精准医学领域的贡献。
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本文引用的文献
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Clin Cancer Res. 2018 Feb 1;24(3):521-531. doi: 10.1158/1078-0432.CCR-17-1597. Epub 2017 Aug 24.
2
Target and Agent Prioritization for the Children's Oncology Group-National Cancer Institute Pediatric MATCH Trial.儿童肿瘤协作组-美国国立癌症研究所儿科MATCH试验的靶点和药物优先排序
J Natl Cancer Inst. 2017 May 1;109(5). doi: 10.1093/jnci/djw274.
3
Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial.用于全国性信号发现临床试验的下一代测序检测方法的分析验证：治疗选择分子分析临床试验
J Mol Diagn. 2017 Mar;19(2):313-327. doi: 10.1016/j.jmoldx.2016.10.007. Epub 2017 Feb 7.
4
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5
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J Mol Diagn. 2016 Jan;18(1):51-67. doi: 10.1016/j.jmoldx.2015.07.006. Epub 2015 Nov 18.
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10
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Oncologist. 2005 Aug;10(7):461-6. doi: 10.1634/theoncologist.10-7-461.
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