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

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ClinicalTrials.gov Identifier: NCT02431078
Recruitment Status : Unknown
Verified April 2015 by wei bo, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 30, 2015
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
wei bo, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment
Stomach Neoplasms Procedure: Routine comprehensive treatment

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
ZEB1 high-expression group
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
Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy

ZEB1 low-expression group
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
Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy




Primary Outcome Measures :
  1. three-year disease free survival rate [ Time Frame: Up to 3 years post-operative ]

Secondary Outcome Measures :
  1. three-year overall survival rate [ Time Frame: Up to 3 years post-operative ]
  2. metastasis and recurrence rate [ Time Frame: Up to 3 years post-operative ]
  3. baseline detection of ZEB1 expression [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Circulating Tumor Cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximate 150 consecutive patients with gastric cancer and CTCS(+) will be enrolled in this study.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431078


Sponsors and Collaborators
wei bo
Investigators
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Study Chair: Wei bo, MD Vice director of the general surgery department, Chinese PLA General Hospital

Publications:

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Responsible Party: wei bo, Vice Director of the general surgery department, Chinese PLA General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02431078     History of Changes
Other Study ID Numbers: experiment20152018
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: April 2015

Keywords provided by wei bo, Chinese PLA General Hospital:
CTCs
ZEB1
gastric cancer

Additional relevant MeSH terms:
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Stomach Neoplasms
Recurrence
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes