肿瘤精准个性化治疗是依据个体全面且精细的分子遗传学检测,对患者进行分子分型并匹配个性化治疗方案的一种新型临床诊疗研究范式.欧美国家在癌症基因组学相关领域的基础和临床转化研究方面较为深入,发起了多项具有世界影响力的肿瘤精准医疗临床研究项目.本研究结合德国在肿瘤精准医疗领域开展的"分子辅助分层用于肿瘤根除研究"(Molecularly Aided Stratification for Tumour Eradication Research,MASTER)项目以及在肿瘤个性化治疗领域的实践探索,概述了德国国家癌症研究体系的整体框架、核心研究机构以及MASTER项目在实施过程中关于患者筛选、样本收集、分子检测、数据分析以及临床转化等一系列的流程要素,分析了其在临床试验伦理与质量管理规范、患者筛选与临床试验入组、生物信息学分析、基因变异功能验证、专家委员会协同等方面具体的做法,以期借鉴MASTER项目的成功经验,为我国今后开展更多基于分子遗传学检测的肿瘤精准诊疗相关的临床试验提供建议,加速我国肿瘤疾病分子分型与患者预后评估的发展.
The Innovative Practice of the German MASTER Project in the Field of Personalized Cancer Treatment
Personalized cancer treatment is a new clinical research paradigm based on comprehensive and fine molecular genetic test-ing and classification of individual patients to match precise treatment strategies.European countries and the United States are relatively developed in genomics related basic and translational medical research and have initiated several clinical cancer research projects of pre-cision medicine.Combined the practical exploration of Molecularly Aided Stratification for Tumour Eradication Research(MASTER)project in Germany in the field of personalized cancer treatment,this study outlined the overall framework of German national cancer research system and the core research institutions involved,summarized a series of process elements related to patient screening,sample collection,molecular detection,data analysis and clinical transformation during the implementation of the MASTER project,and ana-lyzed the specific practices in the clinical trial ethics and quality management norms,patient enrollment,bioinformatics,gene mutation function verification and expert committee coordination,etc.,so as to learn from the successful experience of the MASTER project,and provide reference for carrying out more molecularly genetic testing directed clinical trials in the future and accelerating the development of molecular classification and patient prognosis assessment of tumor diseases in China.
U-PGx projectClinical decision-making systemProspective drug genetic testingEducation project
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