The Expression of ZEB1 in CTCs Associated With Metastasis and Recurrence for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the expression of ZEB1 in CTCs for gastric cancer, its correlation with the clinicopathology of gastric cancer, and the role of ZEB1 in invasion and metastasis in gastric cancer.

Detailed Description
-----------------
Invasion and metastasis of tumors and postoperative recurrence are the main causes of death in patients with gastric cancer and are also the key factors affecting the clinical treatment and prognosis. In this study, the investigators will detect the expression of ZEB1 in different types of CTCs(epithelial,mesenchymal and mixed phenotype) for gastric cancer by CanPatrolTM2 detection technology.Our investigation of the relationship between ZEB1 and the occurrence and development as well as the invasion and metastasis of gastric cancer is expected to provide data for the prognosis and targeted therapy of gastric cancer. Approximate 100 consecutive patients with gastric cancer and CTCs(+) will be enrolled in this study.Detection of ZEB1 expression in CTCs at baseline will show the relationship between ZEB1 and clinicopathological variables. Postoperative follow-up of ZEB1 expression in CTCs will be performed every three months in the first year and every six months in the following two years. The results may indicate the role of ZEB1 in CTCs about invasion and metastasis for gastric cancer .The aim of this study is to clarify the clinical significance of ZEB1 expression in CTCs for gastric cancer.

Official Title
-----------------
The Expression of Zinc Finger E-Box Binding Homeobox 1 (ZEB1) in Circulating Tumor Cells(CTCs) Associated With Metastasis and Recurrence for Gastric Cancer

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Procedure: Routine comprehensive treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven gastric cancer and CTCs(+). Age:older than 18 years old,younger than 80 years old. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition. No obvious surgical contraindications. American Society of Anesthesiology (ASA) score class I, II, or III. Written informed consent. Exclusion Criteria: Severe mental disorder. Pregnancy. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection. History of unstable angina or myocardial infarction within past six months. History of previous neoadjuvant chemotherapy or radiotherapy. History of other malignant disease within past 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ZEB1 high-expression group<br>Participants with ZEB1 high-expression(ZEB1 expression values>the ZEB1 cut-off point) in CTCs for gastric cancer will be assigned to this group.The ZEB1 cut-off point was set at the top quartile.Routine comprehensive treatment will be performed. | Procedure: Routine comprehensive treatment<br>* Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy<br>|
| ZEB1 low-expression group<br>Participants with ZEB1 low-expression(ZEB1 expression values<the ZEB1 cut-off point) in CTCs for gastric cancer will be assigned to this group.The ZEB1 cut-off point was set at the top quartile.Routine comprehensive treatment will be performed. | Procedure: Routine comprehensive treatment<br>* Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three-year disease free survival rate |  | Up to 3 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| three-year overall survival rate |  | Up to 3 years post-operative | 
| metastasis and recurrence rate |  | Up to 3 years post-operative | 
| baseline detection of ZEB1 expression |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTCs, ZEB1, gastric cancer