Application Value of CTCs Detection for Advanced Gastric Cancer Patients

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156777
• Other study ID #: XH-16-038
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: May 15, 2017
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xin Zhou, M.D. & Ph.D.
• Phone: +862125078999
• Email: xinhuacru[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Gastric Cancer
• Neoplastic Cells, Circulating
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression-free survival	Survival duration since radical resection to clinical finding of relapse disease.	Up to 3 years from start of the study
Secondary	Overall survival	Survival duration since radical resection to patient die.	Up to 5 years from start of the study