Circulating Tumor Cells, Gastric Cancer
Conditions
Keywords
Gastric cancer; Circulating tumor cells; Prognosis
Brief summary
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.
Interventions
None listed
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects eligible for enrollment must meet all of the following criteria: 1. 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 2. Men or women aged \>= 18 years and \<=75 years. 3. Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2. 4. Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction. 5. Metastatic disease or locally advanced disease not amenable to curative surgery. 6. Radiographically assessable, non-measurable disease or measurable disease as per RECIST criteria. 7. Life expectancy of at least 12 weeks with tumor and at least 5 years without tumor from the time of enrollment. 8. 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. 9. No prior chemotherapy for advanced disease. -
Exclusion criteria
Subjects meeting any of the following criteria must not be enrolled in the study: 1. Gastric carcinoid, sarcomas, or squamous cell cancer. 2. Pregnant or lactating females. 3. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent. 4. Active Hepatitis B or C or history of an HIV infection. 5. Active uncontrolled infection. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of circulating tumor cell (CTC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile and Portion of circulating tumor cell (CTC) | 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. |
| Progression-free survival | Up to 3 years from start of the study | Survival duration since radical resection to clinical finding of relapse disease. |
| Overall survival | Up to 5 years from start of the study | Survival duration since radical resection to patient die. |
Countries
China
Contacts
Primary ContactXin Zhou, M.D. & Ph.D.
Backup ContactBeiqing Jiang
Outcome results
None listed