Application Value of CTCs Detection for Advanced Gastric Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Circulating Tumor Cells, Gastric Cancer

Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of circulating tumor cell (CTC) | Number of the circulating tumor cell in peripheral blood from advanced gastric cancer patients undergoing D2 radical resection followed by first-line chemotherapy | Up to 2 years from start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile and Portion of circulating tumor cell (CTC) | 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 | 
| Progression-free survival | Survival duration since radical resection to clinical finding of relapse disease. | Up to 3 years from start of the study | 
| Overall survival | Survival duration since radical resection to patient die. | Up to 5 years from start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer; Circulating tumor cells; Prognosis