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Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults (TF)

2019年6月25日 更新者:University Hospital, Lille

Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and general ( presence of metastases , usually liver ). This is the most common cancer in France and, despite surgical treatment of the primary tumor, it is still subject to a high mortality rate due to metastatic evolution, mainly hepatic .

There is currently no specific marker for predicting cancer, the same hardly changed , which would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness. Corroborating evidence that the way the TF plays an important role in the invasive and metastatic potential of CRC. First, various human cancer cell lines express the FT colic. Furthermore, there is a relationship between the importance of monocyte TF expression and the evolutionary potential of human CRC.

The investigators hypothesize that these interest intra-platelet and plasma markers are a reflection of tumor angiogenic potential. And the investigators will verify the superiority of their preoperative levels in the CRC group compared with the control group, normalization of postoperative after surgical resection rates and their possible re-ascent in case of tumor recurrence in the CRC group.

The levy to one month in controls allow us to verify the absence of secondary modification to laparotomy, the colectomy and general anesthesia.

The investigators assume that the rate of soluble TF in peripheral blood of the holders of CRC patients may be a marker of invasion and aggression (i.e. prognosis).

研究概览

详细说明

The study is to measure the TF in the blood, as well as ACE, C reactive protein and E-selectin. The TF will also be measured in the tissue removed during surgery.

研究类型

介入性

注册 (预期的)

120

阶段

  • 第一阶段早期

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。

学习联系方式

研究联系人备份

学习地点

      • Lille、法国、59037
        • 招聘中
        • Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ
        • 接触:

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

All patients, adults, holders of CRC with or without MH in whom surgical resection HEALING is planned .

For witnesses:

- Patients without CCR (preoperative colonoscopy). This control population will verify normal values regulators of angiogenesis recently defined and specificity of these vis-à-vis markers CCR-

Exclusion Criteria:

all situations where the plasma levels of FT antigen are high, in particular:

  • Patients with unstable angina or myocardial infarction in the acute phase (not older than two months)
  • Severe sepsis (hospitalization)
  • Cirrhosis stage Child C
  • Chronic renal failure requiring renal replacement extra
  • Patients with microvascular complications of diabetes
  • Vasculitis
  • Pregnancy and lactation patient on oral contraceptives, or having hormone replacement therapy for menopause

    • Patients with extrahepatic metastases
    • Patients underwent emergency surgery
    • Persons not able to consent

For witnesses:

History of cancer, inflammatory disease, diabetes, regular intake of anti inflammatory drugs.

If during colonoscopy, colorectal cancer was detected, the control patients were excluded from the study -

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

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group CRC
patient with a colorectal cancer
blood samples
实验性的:Group control
Control - volunteers
Blood samples

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
TNM primary colorectal tumor stage
大体时间:Before surgery
soluble blood TNM value will be determined before surgery, and compared between groups.
Before surgery

次要结果测量

结果测量
措施说明
大体时间
TF (blood levels of soluble TF)
大体时间:1 , 6 , 12, 18 and 24 months .5 years
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
1 , 6 , 12, 18 and 24 months .5 years
TF intratumoral (blood levels of TF intratumoral)
大体时间:1 , 6 , 12, 18 and 24 months .5 years
Comparing the pre - operative and post -operative blood levels of soluble TF and TF intratumoral
1 , 6 , 12, 18 and 24 months .5 years
E- selectin and CRP
大体时间:1 , 6 , 12, 18 and 24 months. 5 years
Comparison - soluble TF with blood levels of other circulating proteins: E- selectin and CRP at different times of follow-up.
1 , 6 , 12, 18 and 24 months. 5 years
ACE
大体时间:1 , 6 , 12, 18 and 24 months .5 years
Evaluation of the prognostic value of blood levels of soluble TF and that of ACE blood on the incidence of Metastases Hepatic in patients undergoing CRC and / or hepatic
1 , 6 , 12, 18 and 24 months .5 years
Interaction plate / tumor cell
大体时间:1 , 6 , 12, 18 and 24 months .5 years
Quantifying the interaction plate / tumor cell by measuring intraplatelet regulatory proteins and angiogenesis markers of platelet activation and plasma compare the
1 , 6 , 12, 18 and 24 months .5 years

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

  • 研究主任:ZERBIB Philippe, Prof、CHRU of Lille

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)

2009年6月22日

初级完成 (预期的)

2020年6月1日

研究完成 (预期的)

2020年6月1日

研究注册日期

首次提交

2014年6月24日

首先提交符合 QC 标准的

2014年12月1日

首次发布 (估计)

2014年12月2日

研究记录更新

最后更新发布 (实际的)

2019年6月26日

上次提交的符合 QC 标准的更新

2019年6月25日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2008-09/0908
  • 2009-A00264-53 (其他标识符:ID-RCB number, ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Group CRC的临床试验

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