Application Value of CTCs Detection for Advanced Gastric Cancer Patients

Shanghai Jiao Tong University

Status: Unknown

Conditions: Gastric Cancer; Circulating Tumor Cells

Study type: Observational

Funder types: Other

Identifiers

NCT03156777

XH-16-038

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. -