Clinical trial NCT02431078: The Expression of ZEB1 in CTCs Associated With Metastasis and Recurrence 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Keywords: CTCs
ZEB1
gastric cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximate 150 consecutive patients with gastric cancer and CTCS(+) will be enrolled in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: three-year disease free survival rate
timeFrame: Up to 3 years post-operative
Secondary outcomes:
measure: three-year overall survival rate
timeFrame: Up to 3 years post-operative
measure: metastasis and recurrence rate
timeFrame: Up to 3 years post-operative
measure: baseline detection of ZEB1 expression
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Vice director of the general surgery department, Chinese PLA General Hospital
name: Wei bo, MD
role: STUDY_CHAIR
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