Clinical trial NCT03156777: Application Value of CTCs Detection for Advanced Gastric Cancer Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor Cells
Gastric Cancer
Keywords: Gastric cancer; Circulating tumor cells; Prognosis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced gastric cancer patients

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Number of circulating tumor cell (CTC)
timeFrame: Up to 2 years from start of study
Secondary outcomes:
measure: Profile and Portion of circulating tumor cell (CTC)
timeFrame: Up to 2 years from start of study
measure: Progression-free survival
timeFrame: Up to 3 years from start of the study
measure: Overall survival
timeFrame: Up to 5 years from start of the study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei Lu, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yinbing Liu, M.D. & Ph.D.
role: STUDY_CHAIR
References: