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临床试验生物样本管理的现状与挑战 被引量:2
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作者 潘睿 左祥林 +7 位作者 刘小林 王洁 汪秀琴 黄旭 沙莉莉 张妞 万莉 鲍军 《中国医学伦理学》 2023年第6期606-612,共7页
随着临床试验的快速发展,基于生物样本开展的相关医学研究和分子检测与临床试验的进展紧密关联,使得生物样本在临床试验中的作用愈发明显,其规范化的监管模式是开展高质量临床试验的重要前提。尽管与临床试验相关的法律法规日趋完善,但... 随着临床试验的快速发展,基于生物样本开展的相关医学研究和分子检测与临床试验的进展紧密关联,使得生物样本在临床试验中的作用愈发明显,其规范化的监管模式是开展高质量临床试验的重要前提。尽管与临床试验相关的法律法规日趋完善,但仍有大量的与生物样本相关的不良事件发生,严重影响临床试验的进展与结果,是当前面临的重要挑战之一。因此,亟须强化对生物样本的监管,完善现阶段临床试验中生物样本的管理方式。通过深入探讨国内外临床试验中生物样本的管理现状,分析生物样本监管过程中存在的问题,进一步梳理现有的相关政策法规和《临床试验生物样本伦理管理指南》对生物样本管理的新补充,为优化临床试验生物样本的管理模式提供建议与思考。 展开更多
关键词 生物样本 伦理管理 临床试验 法律法规 样本管理
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肺腺癌中SETD7的表达及其临床意义
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作者 陈美茹 姚宁宁 +4 位作者 孙润哲 唐洁 刘如丽 于倩倩 孙瑞芳 《临床与实验病理学杂志》 CAS 北大核心 2023年第7期816-821,共6页
目的探讨肺腺癌中SETD7的表达及其临床意义。方法采用qRT-PCR技术检测22例肺腺癌组织和15例癌旁组织中SETD7 mRNA的表达水平;采用免疫组化GTVision法检测162例肺腺癌和57例癌旁组织中SETD7蛋白表达,分析其表达水平与肺腺癌临床病理特征... 目的探讨肺腺癌中SETD7的表达及其临床意义。方法采用qRT-PCR技术检测22例肺腺癌组织和15例癌旁组织中SETD7 mRNA的表达水平;采用免疫组化GTVision法检测162例肺腺癌和57例癌旁组织中SETD7蛋白表达,分析其表达水平与肺腺癌临床病理特征及预后的关系。结果与癌旁组织相比,肺腺癌组织中SETD7 mRNA表达水平明显升高(t=5.212,P<0.0001);同时,SETD7在肺腺癌组织中的蛋白表达水平亦升高,其高表达率(58.6%,95/162)高于癌旁组织(0,0/57)(P<0.001)。SETD7蛋白表达与肺腺癌临床分期(c-TNM分期)相关(P<0.05),与患者性别、年龄、吸烟、饮酒、p-TNM分期、淋巴结转移、复发、EGFR和KRAS突变以及PD-L1表达水平均无关(P>0.05)。Kaplan-Meier生存分析:SETD7蛋白高表达组患者生存率明显低于SETD7低表达组(P<0.0001)。Cox单因素及多因素回归分析显示,SETD7蛋白高表达是影响肺腺癌患者预后的独立危险因素(P<0.001)。结论SETD7在肺腺癌组织中表达明显上调,同时SETD7高表达是影响肺腺癌患者预后的独立危险因素,其可以作为判断肺腺癌患者进展的潜在生物学标志物。 展开更多
关键词 肺肿瘤 腺癌 SETD7 免疫组织化学 预后
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F框/WD-40域蛋白7在乳腺癌预后预测中的价值及功能研究
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作者 罗飞 罗宁 +1 位作者 李晓宇 贾红燕 《中华实验外科杂志》 CAS 2024年第6期1265-1269,共5页
目的探究F框/WD-40域蛋白7(FBXW7)在乳腺癌(BC)发生发展中的临床意义及功能。方法利用免疫组织化学技术对BC组织芯片中FBXW7的表达进行检测,受试者工作特征曲线(ROC)曲线确定FBXW7表达的阈值,使用Kaplan-Meier生存分析和比例风险回归模... 目的探究F框/WD-40域蛋白7(FBXW7)在乳腺癌(BC)发生发展中的临床意义及功能。方法利用免疫组织化学技术对BC组织芯片中FBXW7的表达进行检测,受试者工作特征曲线(ROC)曲线确定FBXW7表达的阈值,使用Kaplan-Meier生存分析和比例风险回归模型(COX)预测FBXW7表达与患者预后的关系。向BC细胞系MCF7和MDA-MB-231转染pcDNA3-FBXW7wt质粒,实时荧光定量聚合酶链反应(qPCR)验证过表达效率。通过噻唑蓝(MTT)法和集落形成实验检测细胞增殖;可穿透性细胞培养小室检测细胞迁移。统计学方法分别采用独立样本t检验和方差分析。结果FBXW7在BC组织中的表达低于癌旁正常组织(8.537±0.536比9.619±0.360,t=21.080,P<0.05),低表达与BC患者预后差相关(104.143比133.714,χ^(2)=6.146,P<0.05),且在年龄≥60岁(90.333比113.615,χ^(2)=4.747,P<0.05)、右乳为病灶部位(107.150比137.727,χ^(2)=4.685,P<0.05)、病理T2(92.700比114.760,χ^(2)=4.063,P<0.05)、有淋巴结转移(104.083比132.211,χ^(2)=4.124,P<0.05)、TNMⅢ期(87.062比130.333,χ^(2)=5.494,P<0.05)、雌激素受体(ER)阳性(97.381比133.478,χ^(2)=4.902,P<0.05)和人表皮生长因子受体2(Her-2)阳性(93.181比131.727,χ^(2)=6.219,P<0.05)的BC人群中,FBXW7低表达患者的总生存期明显短于FBXW7高表达患者。单因素[比值比(OR):3.374;95%可信区间(CI):1.213~9.382,P<0.05]和多因素COX分析(OR:3.335;95%CI:1.062~10.476;P<0.05),结果显示FBXW7是BC患者生存状态的危险因素。MCF7和MDA-MB-231细胞FBXW7过表达效率分别为67.129倍[(0.998±0.055)比(66.972±0.423),t=78.560,P<0.05]和39.523倍[(0.998±0.050)比(39.456±0.210),t=54.640,P<0.05]。过表达FBXW7可显著抑制BC细胞系MCF7和MDA-MB-231细胞的增殖[MCF7组第4天为(1.639±0.045)比(1.141±0.842),t=10.400,P<0.05;MDA-MB-231组第2天为(0.519±0.030)比(0.410±0.025),t=5.447,P<0.05;第3天为(1.416±0.68)比(1.129±0.022),t=7.939,P<0.05;第4天为(1.910±0.071)比(1.247±0.069),t=13.310,P<0.05]、克隆形成[(211.333±7.039)比(92.667±3.681),t=21.120,P<0.05;(133.000±7.348)比(28.333±3.858),t=17.830,P<0.05]和迁移能力[(286.333±8.993)比(82.000±7.257),t=25.000,P<0.05;(176.000±5.099)比(65.333±6.649),t=18.680,P<0.05]。结论FBXW7可作为BC患者预后预测的指标,在BC中发挥抑癌基因的作用。 展开更多
关键词 F框/WD-40域蛋白7 乳腺癌 预后 抑癌基因
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Proteomic Stratification of Prognosis and Treatment Options for Small Cell Lung Cancer
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作者 Zitian Huo Yaqi Duan +19 位作者 Dongdong Zhan Xizhen Xu Nairen Zheng Jing Cai Ruifang Sun Jianping Wang Fang Cheng Zhan Gao Caixia Xu Wanlin Liu Yuting Dong Sailong Ma Qian Zhang Yiyun Zheng Liping Lou Dong Kuang Qian Chu Jun Qin Guoping Wang Yi Wang 《Genomics, Proteomics & Bioinformatics》 SCIE CAS CSCD 2024年第2期81-92,共12页
Small cell lung cancer(SCLC)is a highly malignant and heterogeneous cancer with limited therapeutic options and prognosis prediction models.Here,we analyzed formalin-fixed,paraffin-embedded(FFPE)samples of surgical re... Small cell lung cancer(SCLC)is a highly malignant and heterogeneous cancer with limited therapeutic options and prognosis prediction models.Here,we analyzed formalin-fixed,paraffin-embedded(FFPE)samples of surgical resections by proteomic profiling,and stratified SCLC into three proteomic subtypes(S-I,S-II,and S-III)with distinct clinical outcomes and chemotherapy responses.The proteomic subtyping was an independent prognostic factor and performed better than current tumor–node–metastasis or Veterans Administration Lung Study Group staging methods.The subtyping results could be further validated using FFPE biopsy samples from an independent cohort,extending the analysis to both surgical and biopsy samples.The signatures of the S-II subtype in particular suggested potential benefits from immunotherapy.Differentially overexpressed proteins in S-III,the worst prognostic subtype,allowed us to nominate potential therapeutic targets,indicating that patient selection may bring new hope for previously failed clinical trials.Finally,analysis of an independent cohort of SCLC patients who had received immunotherapy validated the prediction that the S-II patients had better progression-free survival and overall survival after first-line immunotherapy.Collectively,our study provides the rationale for future clinical investigations to validate the current findings for more accurate prognosis prediction and precise treatments. 展开更多
关键词 Small cell lung cancer PROTEOMICS PROGNOSIS Chemotherapy response IMMUNOTHERAPY
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Proteomics provides individualized options of precision medicine for patients with gastric cancer 被引量:5
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作者 Wenwen Huang Dongdong Zhan +30 位作者 Yazhuo Li Nairen Zheng Xin Wei Bin Bai Kecheng Zhang Mingwei Liu Xuefei Zhao Xiaotian Ni Xia Xia Jinwen Shi Cheng Zhang Zhihao Lu Jiafu Ji Juan Wang Shiqi Wang Gang Ji Jipeng Li Yongzhan Nie Wenquan Liang Xiaosong Wu Jianxin Cui Yongsheng Meng Feilin Cao Tieliu Shi Weimin Zhu Yi Wang Lin Chen Qingchuan Zhao Hongwei Wang Lin Shen Jun Qin 《Science China(Life Sciences)》 SCIE CAS CSCD 2021年第8期1199-1211,共13页
While precision medicine driven by genome sequencing has revolutionized cancer care,such as lung cancer,its impact on gastric cancer(GC)has been minimal.GC patients are routinely treated with chemotherapy,but only a f... While precision medicine driven by genome sequencing has revolutionized cancer care,such as lung cancer,its impact on gastric cancer(GC)has been minimal.GC patients are routinely treated with chemotherapy,but only a fraction of them receive the clinical benefit.There is an urgent need to develop biomarkers or algorithms to select chemo-sensitive patients or apply targeted therapy.Here,we carried out retrospective analyses of 1,020 formalin-fixed,paraffin-embedded GC surgical resection samples from 5 hospitals and developed a mass spectrometry-based workflow for proteomic subtyping of GC.We identified two proteomic subtypes:the chemo-sensitive group(CSG)and the chemo-insensitive group(CIG)in the discovery set.The 5-year overall survival of CSG was significantly improved in patients who had received adjuvant chemotherapy after surgery compared with those who received surgery only(64.2%vs.49.6%;Cox P-value=0.002),whereas no such improvement was observed in CIG(50.0%vs.58.6%;Cox P-value=0.495).We validated these results in an independent validation set.Further,differential proteome analysis uncovered 9 FDA-approved drugs that may be applicable for targeted therapy of GC.A prospective study is warranted to test these findings for future GC patient care. 展开更多
关键词 PATIENTS CHEMOTHERAPY cancer
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Critically dysregulated signaling pathways and clinical utility of the pathway biomarkers in lymphoid malignancies
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作者 Rui-Fang Sun Qian-Qian Yu Ken H. Young 《Chronic Diseases and Translational Medicine》 CSCD 2018年第1期29-44,共16页
Accumulating evidence confirmed that many dysregulated signaling pathways and aberrant genetic alterations contribute to the oncogenesis and heterogeneity of lymphoid malignancies. Therapeutically targeting dysregulat... Accumulating evidence confirmed that many dysregulated signaling pathways and aberrant genetic alterations contribute to the oncogenesis and heterogeneity of lymphoid malignancies. Therapeutically targeting dysregulating signaling pathways and their hidden oncogenic biomarkers are becoming available, but did not show desired therapeutic effect in current clinical practice. It is meaningful to further understand the underlying mechanisms of the dysregulated signaling pathways and to address the potential utility of pathway-related biomarkers. To precisely identify the dysregulation of signaling pathways and the 'driver' oncogenic biomarkers, as well as to develop reliable and reproducible risk-stratification based on biomarkers will be challenging. Never-theless, pathway-based targeted therapy will raise the hope to improve the outcomes of the patients with lymphoid malignancies, especially with aggressive types, and the efficient utility of pathway-related biomarkers in diagnosis, prognosis, prediction of lymphoid malignancies may also be able to power precision medicine. 展开更多
关键词 LYMPHOMA SIGNALING PATHWAY BIOMARKER THERAPEUTIC target
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