Venous Thromboembolism in Advanced Gastric Cancer Patients
2020年1月6日 更新者:Yoon-Koo Kang、Asan Medical Center
The Incidence and Risk Factors of Venous Thromboembolism in Advanced Gastric Cancer Patients: Prospective Observational Study
Venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep vein thrombosis (DVT), is a common complication and leading cause of death in cancer patients.
Large, population-based studies have shown that patients with cancer have four- to seven-fold increased risk of developing VTE compared with patients without cancer.
VTE would be frequent in patients with advanced gastric cancer, especially associated chemotherapy.
However, relatively few studies have been conducted regarding the incidence of VTE in Asian cancer patients.
According to previous review, Asian patients significantly lower risk of developing VTE.
The rate of VTE with advanced gastric cancer, and associated chemotherapy is not known in Asian patients.
In addition, the impact of VTE on overall survival has not been documented in these patients.
研究概览
地位
完全的
条件
详细说明
Primary objectives - To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
Secondary objectives
- To investigate the significant impact of VTE on overall survival and in this population
研究类型
观察性的
注册 (实际的)
259
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
-
-
-
Seoul、大韩民国、138-736
- Asan Medical Center, University of Ulsan College of Medicine
-
-
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
概率样本
研究人群
All patients of advanced gastric cancer with palliative chemotherapy
描述
Inclusion Criteria:
- Histologically documented gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 years or older
- Locally advanced (inoperable) or metastatic gastric cancer, initially diagnosed, recurrent gastric cancer
- Performance status (ECOG scale) : 0-2
- Adequate bone marrow function:
- Adequate renal function
- Adequate hepatic function:
- Required to be at the start of a new chemotherapy regimen
- Received chemotherapy one cycle or more
- Adequate follow-up for at least 12 weeks
- Patients should sign a written informed consent before study entry
Exclusion Criteria:
- Previously exposed to chemotherapy exception adjuvant or neoadjuvant therapy
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
- Presence of CNS metastasis
- Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery. Patient received curative operation or RFA for metastatic disease.
- Significant traumatic injury within 4 weeks prior to enrollment
Serious illness or medical conditions, as follows:
- Congestive heart failure (NYHA class III or IV)
- Unstable angina or myocardial infarction within the past 12 months
- Significant arrhythmia requiring medication and conduction abnormality such as over 2nd degree AV block
- Uncontrolled hypertension
- Liver cirrhosis (≥ Child class B)
- Psychiatric disorder that may interfere with protocol compliance
- Unstable diabetes mellitus
- Active infection
- Superficial thrombophlebitis, transient ischemic attacks, and thrombosis occurring in setting of disseminated intravascular coagulation
- Pregnant or lactating women
- Hormonal replacement therapy within 4 weeks
- Chronic oral treatment with corticosteroid unless initiated > 6 months prior to study entry and at low dose (≤ 20mg methylprednisolone or equivalent)
- Warfarin of heparin therapy
- Not able or willing to give informed consent
- Any patients judged by the investigator to be unfit to participate in 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
队列和干预
团体/队列 |
---|
Thromboembolism
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population
大体时间:2 years
|
2 years
|
次要结果测量
结果测量 |
大体时间 |
---|---|
To investigate the significant impact of VTE on overall survival and in this population
大体时间:2 years
|
2 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
- 首席研究员:Yoon-Koo Kang, MD,PhD、Asan Medical Center
- 首席研究员:Baek-Yeol Ryoo, MD,PhD、Asan Medical Center
- 首席研究员:Min-Hee Ryu, MD,PhD、Asan Medical Center
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12月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2010年1月12日
首先提交符合 QC 标准的
2010年1月12日
首次发布 (估计)
2010年1月13日
研究记录更新
最后更新发布 (实际的)
2020年1月7日
上次提交的符合 QC 标准的更新
2020年1月6日
最后验证
2020年1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.
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