NCT03156777Unknown不适用
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
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of circulating tumor cell (CTC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) <=
- •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. -
排除标准
- •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. -
结局指标
主要结局
Number of circulating tumor cell (CTC)
时间窗: Up to 2 years from start of study
Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy
次要结局
- Profile and Portion of circulating tumor cell (CTC)(Up to 2 years from start of study)
- Progression-free survival(Up to 3 years from start of the study)
- Overall survival(Up to 5 years from start of the study)
研究者
研究点 (1)
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