利用基因组学进行癌症临床试验的最新趋势

IF 0.3 Q3 MEDICINE, GENERAL & INTERNAL Journal of The Korean Medical Association Pub Date : 2023-12-10 DOI:10.5124/jkma.2023.66.12.716
H. Ryu
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引用次数: 0

摘要

背景:分子生物学和基因组学的最新进展彻底改变了人们对癌症错综复杂的分子基础的认识。现在,通过下一代测序分析可以确定特定的可操作基因改变。这一突破为肿瘤学中的精准医疗铺平了道路,重新定义了传统的临床试验格局,实现了个性化的癌症治疗方法:向精准医疗的转变从根本上改变了传统的 1-4 期临床试验方案。个性化疗法不再使用统一的治疗路径,而是根据患者的基因特征进行设计。肿瘤诊断临床试验正成为一个突出的概念,它包含创新的适应性设计,使治疗适应特定的基因变异。伞式研究、篮式试验、平台研究和主观察试验等主方案就是这种转变的例证:国际精准医学研究的特点是示范性研究,如美国的 NCI-MATCH 研究、荷兰的药物再发现协议研究和美国的靶向制剂和剖析利用登记研究。韩国肿瘤学研究还通过 K-MASTER 和韩国精准医学网络小组等倡议,为精准医学的国际努力做出了贡献,该小组正在为全球精准医学运动做出值得称道的贡献。
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Latest trends in cancer clinical trials using genomics
Background: Recent advances in molecular biology and genomics have revolutionized the understanding of the intricate molecular underpinnings of cancer. Next-generation sequencing analysis now allows identification of specific actionable genetic alterations. This breakthrough has paved the way for precision medicine in oncology, redefining the conventional clinical trial landscape and enabling personalized approaches to cancer treatment.Current Concepts: The shift toward precision medicine involves a fundamental departure from the traditional Phases 1–4 clinical trial protocols. Instead of using uniform treatment pathways, personalized therapies are designed based on the genetic profiles of individual patients. Tumor-agnostic clinical trials are becoming as a prominent concept, encompassing innovative adaptive designs that adapt treatments to specific genetic variations. Master protocols such as umbrella studies, basket trials, platform studies, and master observational trials exemplify this transformation.Discussion and Conclusion: International precision medicine research is characterized by exemplar studies such as the NCI-MATCH study in the United States, the Drug Rediscovery Protocol study in the Netherlands, and the Targeted Agent and Profiling Utilization Registry study in the United States. Korean oncology research also contributed to the international effort in precision medicine through initiatives like K-MASTER and the Korean Precision Medicine Networking Group, which is making commendable contributions to the global precision medicine movements.
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来源期刊
Journal of The Korean Medical Association
Journal of The Korean Medical Association Medicine-General Medicine
CiteScore
0.50
自引率
0.00%
发文量
84
审稿时长
4-8 weeks
期刊介绍: The Journal of the Korean Medical Association (JKMA) is the official peer-reviewed, open-access, monthly journal of the Korean Medical Association (KMA). It contains articles in Korean or English. Its abbreviated title is ''J Korean Med Assoc''. The aims of the Journal include contributing to the treatment of and preventing diseases of public health importance and to improvement of health and quality of life through sharing the state-of the-art scientific information on medicine by the members of KMA and other national and international societies.
期刊最新文献
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