【佳学基因检测】癌症基因检测指导的基因治疗：需要考虑的各个方面

如何知道小孩是否有基因突变评价

探索肿瘤的基因组学特征与治疗方案设计时体会到《Cancer Gene Ther》在. 2015 Dec;22(12):554-63.发表了一篇题目为《癌症基因治疗：批准的监管考虑》肿瘤靶向药物治疗基因检测临床研究文章。该研究由S R Husain, J Han, P Au, K Shannon, R K Puri等完成。促进了肿瘤的精准治疗与个性化用药的发展，进一步强调了基因信息检测与分析的重要性。

肿瘤靶向药物及精准治疗临床研究内容关键词：

癌症,基因检测,基因治疗,监管,条例,考虑内容

肿瘤靶向治疗基因检测临床应用结果

快速变化的基因治疗领域为癌症患者带来了许多创新的治疗基因解码基因检测的研究方法。癌症和免疫细胞的基因改造以及溶瘤病毒和细菌的使用取得了进展，导致了许多癌症治疗的临床试验，其中一些已进入后期产品开发。在撰写本文时，还没有基因治疗产品获得美国食品和药物管理局 (FDA) 的批准。一些关键的科学和监管问题包括对基因转移载体生物学的理解、载体在体外和动物模型中的安全性、最佳基因转移、在宿主中的长期持久性或整合、病毒的脱落和维持转基因表达的能力体内所需的时间。由于这些产品的生物学复杂性，FDA 鼓励对临床前安全性测试项目采用灵活的、数据驱动的基因解码基因检测的研究方法。临床试验设计应基于基因治疗产品的独特性，并应确保入组受试者的安全。本文重点关注基因治疗产品开发的监管考虑，并讨论 FDA 已发布的指导文件。基因解码基因检测的研究结论：LRSAM1 在绒癌中发挥致瘤作用。通过激活 p53/p21 信号通路和阻碍绒癌细胞增殖、迁移流动和侵袭力，LRSAM1 敲低减缓了疾病的进程。对于绒毛膜癌的诊断和治疗，它是一种新的治疗靶点。

肿瘤发生与复发转移国际数据库描述：

The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.Conclusion: LRSAM1 exerts tumorigenic roles in choriocarcinoma. Via the activating of the p53/p21 pathway of signaling and impediment of choriocarcinoma cell proliferating, migratory flow, and invasive force, LRSAM1 knockdown slows the course of the disease. For choriocarcinoma diagnosis and treatment, it serves as a new therapeutic target.