使用基质辅助激光解吸/电离串联飞行时间 (MALDI-TOF/TOF) 的蛋白质组学方法研究直肠癌放化疗后的肿瘤反应 (PROTEORECTUM)
2013年5月7日 更新者:University Hospital, Bordeaux
局部晚期直肠腺癌的治疗包括术前放化疗和全直肠系膜切除术,以减少肿瘤浸润,促进肿瘤手术并提高生存率。
这些患者中约有百分之五十是良好反应者,即他们的直肠壁和区域淋巴结中的肿瘤浸润减少,以便在病理评估后分级为 ypT0 至 T2 N0(所谓的降期)。
相反,不良反应者(ypT3-4 和/或 N+)对标准术前放化疗不敏感,他们的生存率低于良好反应者。
到目前为止,在对手术标本进行病理评估之前,无法预测对术前放化疗的反应。
对术前放化疗反应良好和不良反应者的血清进行蛋白质组学分析,可以识别肿瘤反应的早期生物标志物,并随后调整治疗以提高大多数患者的术前治疗效率和生存率。
研究概览
地位
完全的
条件
详细说明
在对直肠标本进行病理学评估之前,无法预测局部晚期直肠腺癌术前放化疗反应的好坏。
这项前瞻性单中心研究的目的是寻找早期血清生物标志物,以使用蛋白质组学方法预测接受术前放化疗 (45 Gy) 治疗的直肠腺癌患者的肿瘤反应(好反应和坏反应)。
将招募所有患有局部晚期直肠腺癌的患者。
将在术前、术前治疗期间和手术前连续收集血清样本,并使用 MALDI-TOF-TOF 方法进行分析。
蛋白质组学分析将与病理反应相关联,以确定肿瘤反应的潜在早期生物标志物。
研究类型
观察性的
注册 (实际的)
46
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Bordeaux、法国、33076
- Laboratoire d'anatomie pathologique, University Hospital, Bordeaux
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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 至 80年 (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
直肠癌患者
描述
纳入标准:
- T3T4 或 N+ M0 直肠癌
- 经组织学证实的腺癌
- 距肛缘 0 至 15 厘米
- 患者至少年满 18 岁
- ECOG 表现状态 </= 2
- 患者和医生已签署知情同意书
排除标准:
- 转移性疾病
- T1-T2 N0 直肠癌
- 放疗或化疗的禁忌证
- 癌症史
- 严重肾功能不全
- 有症状的心脏或冠状动脉功能不全
- 患者纳入试验
- 既往接受过这种癌症的放疗或化疗
- 未采取避孕措施
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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良好和不良反应者之间早期血清生物标志物的差异表达。
大体时间:入组时和开始放化疗后 24-48 小时
|
入组时和开始放化疗后 24-48 小时
|
次要结果测量
结果测量 |
大体时间 |
---|---|
术前期间分离的生物标志物的修饰
大体时间:入组时、放化疗开始后 24-48 小时、放化疗结束时(第 6 周)和手术前
|
入组时、放化疗开始后 24-48 小时、放化疗结束时(第 6 周)和手术前
|
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。
调查人员
- 学习椅:Paul PEREZ, MD、University Hospital Bordeaux, France
- 首席研究员:Anne RULLIER, MD、University Hospital Bordeaux, France
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。
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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
2009年5月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2009年3月4日
首先提交符合 QC 标准的
2009年3月4日
首次发布 (估计)
2009年3月5日
研究记录更新
最后更新发布 (估计)
2013年5月9日
上次提交的符合 QC 标准的更新
2013年5月7日
最后验证
2013年5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.