尿路上皮癌患者的预后生物标志物
2021年4月29日 更新者：Hellenic Cooperative Oncology Group
铂类方案治疗的尿路上皮癌患者预后生物标志物的调查
膀胱癌 (BC) 是一种结果不佳的异质性恶性肿瘤。尽管进行了治疗，但 MIBC 的 5 年总生存率低于 50%，许多患者反应迟钝或不适应，因此需要生物标志物来选择最有可能反应或适合治疗的患者
研究概览
地位
完全的
条件
详细说明
在这项研究中，评估了最频繁突变的基因与临床病理学特征之间的关联，以及在总生存期 (OS) 方面，顶级突变和 DNA 损伤反应 (DDR) 突变基因中存在突变的预后意义。
此外，测量了总体肿瘤浸润淋巴细胞 (TIL) 密度，通过免疫组织化学分析了 PD-L1、四种 MMR 蛋白（MLH1、MSH2、MSH6 和 PMS2）和肿瘤或间质 CD8+ 细胞毒性 T 淋巴细胞浸润的表达，并评估了它们与相互之间，顶级突变基因和可用的临床病理学参数以及它们在预后中的作用。
研究类型
观察性的
注册 (实际的)
66
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
这是对接受铂方案治疗的尿路上皮癌患者的生物样本进行的跨国分析。
患者已在希腊合作肿瘤学组 (HeCOG) 附属的肿瘤科室接受治疗。
描述
纳入标准：
- 位于膀胱的尿路上皮癌
- 在新辅助治疗中接受铂类方案治疗的患者。 辅助环境
- 使用生物材料的书面知情同意书
排除标准：
-
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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尿路上皮癌患者突变谱的评估
大体时间：长达 5 年
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长达 5 年
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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突变谱与 PD-L1 表达的关联
大体时间：长达 5 年
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长达 5 年
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突变的预后意义与总体生存率的关联
大体时间：长达 5 年
|
长达 5 年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2000年5月1日
初级完成 (实际的)
2017年3月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2021年4月29日
首先提交符合 QC 标准的
2021年4月29日
首次发布 (实际的)
2021年5月4日
研究记录更新
最后更新发布 (实际的)
2021年5月4日
上次提交的符合 QC 标准的更新
2021年4月29日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.