Application Value of CTCs Detection for Advanced Gastric Cancer Patients
A Single Center Observational Study to Evaluate the Application Value of Circulating Tumor Cell Detection for Advanced Gastric Cancer Patients in Prediction of the Prognosis and Evaluation of the Outcome of Adjuvant Chemotherapy
Evaluating the application value of a new circulating tumor cell detection method for advanced gastric cancer patients in prediction of the prognosis and early evaluation of the result of postoperation adjuvant chemotherapy.
研究概览
研究类型
观察性的
注册 (预期的)
200
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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Shanghai
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Shanghai、Shanghai、中国、200092
- 招聘中
- Xinhua Hospital
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接触:
- Beiqing Jiang
- 电话号码:+862125078922
- 邮箱:xinhuakeyan@163.com
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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 75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
Advanced gastric cancer patients
描述
Inclusion Criteria:
Subjects eligible for enrollment must meet all of the following criteria:
- Provide signed informed consent. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the Independent Ethic Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of any study-specific procedures
- Men or women aged >= 18 years and <=75 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG) <= 2.
- Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction.
- Metastatic disease or locally advanced disease not amenable to curative surgery.
- Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria.
- Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment.
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- No prior chemotherapy for advanced disease. -
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
- Gastric carcinoid, sarcomas, or squamous cell cancer.
- Pregnant or lactating females.
- Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
- Active Hepatitis B or C or history of an HIV infection.
- Active uncontrolled infection. -
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 |
措施说明 |
大体时间 |
---|---|---|
Number of circulating tumor cell (CTC)
大体时间:Up to 2 years from start of study
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Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy
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Up to 2 years from start of study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Profile and Portion of circulating tumor cell (CTC)
大体时间:Up to 2 years from start of study
|
Profile and Portion of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy.
There are three type of CTCs: epithelial type CTC,mesenchymal type CTC and mixed type CTC.
The portion of different type of CTC were calculated, for example: the portion of epithelia type CTC number to total CTCs,etc.
|
Up to 2 years from start of study
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Progression-free survival
大体时间:Up to 3 years from start of the study
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Survival duration since radical resection to clinical finding of relapse disease.
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Up to 3 years from start of the study
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Overall survival
大体时间:Up to 5 years from start of the study
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Survival duration since radical resection to patient die.
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Up to 5 years from start of the study
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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。
调查人员
- 首席研究员:Wei Lu, M.D. & Ph.D.、Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- 学习椅:Yinbing Liu, M.D. & Ph.D.、Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
2016年1月1日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2020年12月1日
研究注册日期
首次提交
2016年11月30日
首先提交符合 QC 标准的
2017年5月15日
首次发布 (实际的)
2017年5月17日
研究记录更新
最后更新发布 (实际的)
2017年5月17日
上次提交的符合 QC 标准的更新
2017年5月15日
最后验证
2016年11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.