Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatment routine comprehensive treatment
Sponsor wei bo
Start date June 2015
End date June 2018
Trial size 100 participants
Trial identifier NCT02431078, experiment20152018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
routine comprehensive treatment
Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy
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.
routine comprehensive treatment
Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy

Primary Outcomes

Measure
three-year disease free survival rate
time frame: Up to 3 years post-operative

Secondary Outcomes

Measure
three-year overall survival rate
time frame: Up to 3 years post-operative
metastasis and recurrence rate
time frame: Up to 3 years post-operative
baseline detection of ZEB1 expression
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Pathologically proven gastric cancer and CTCs(+). 2. Age:older than 18 years old,younger than 80 years old. 3. 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. 4. No obvious surgical contraindications. 5. American Society of Anesthesiology (ASA) score class I, II, or III. 6. Written informed consent. Exclusion Criteria: 1. Severe mental disorder. 2. Pregnancy. 3. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection. 4. History of unstable angina or myocardial infarction within past six months. 5. History of previous neoadjuvant chemotherapy or radiotherapy. 6. History of other malignant disease within past 5 years.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.