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Status unknownNCT02431078Updated Jul 29, 2015

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

An observational study in Stomach Neoplasms, sponsored by wei bo. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by wei bo · Observational

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Stomach Neoplasms

Keywords

  • CTCs
  • ZEB1
  • gastric cancer
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 100 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

wei bo is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureRoutine comprehensive treatment

    Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy

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What researchers measure

Primary outcomes

  1. three-year disease free survival rate

    Time frame: Up to 3 years post-operative

Secondary outcomes

  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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Barriere G, Fici P, Gallerani G, Fabbri F, Zoli W, Rigaud M. Circulating tumor cells and epithelial, mesenchymal and stemness markers: characterization of cell subpopulations. Ann Transl Med. 2014 Nov;2(11):109. doi: 10.3978/j.issn.2305-5839.2014.10.04. PubMed 25489583 ↗
  • Toss A, Mu Z, Fernandez S, Cristofanilli M. CTC enumeration and characterization: moving toward personalized medicine. Ann Transl Med. 2014 Nov;2(11):108. doi: 10.3978/j.issn.2305-5839.2014.09.06. PubMed 25489582 ↗
  • Okugawa Y, Toiyama Y, Tanaka K, Matsusita K, Fujikawa H, Saigusa S, Ohi M, Inoue Y, Mohri Y, Uchida K, Kusunoki M. Clinical significance of Zinc finger E-box Binding homeobox 1 (ZEB1) in human gastric cancer. J Surg Oncol. 2012 Sep 1;106(3):280-5. doi: 10.1002/jso.22142. Epub 2011 Nov 17. PubMed 22095522 ↗
  • Yabusaki N, Yamada S, Murai T, Kanda M, Kobayashi D, Tanaka C, Fujii T, Nakayama G, Sugimoto H, Koike M, Nomoto S, Fujiwara M, Kodera Y. Clinical significance of zinc-finger E-box binding homeobox 1 mRNA levels in peritoneal washing for gastric cancer. Mol Clin Oncol. 2015 Mar;3(2):435-441. doi: 10.3892/mco.2014.462. Epub 2014 Nov 20. PubMed 25798282 ↗
  • Jia B, Liu H, Kong Q, Li B. Overexpression of ZEB1 associated with metastasis and invasion in patients with gastric carcinoma. Mol Cell Biochem. 2012 Jul;366(1-2):223-9. doi: 10.1007/s11010-012-1299-6. Epub 2012 Mar 31. PubMed 22466758 ↗
  • Yang X, Wang Q, Dai W, Zhang J, Chen X. Overexpression of zinc finger E-box binding homeobox factor 1 promotes tumor invasiveness and confers unfavorable prognosis in esophageal squamous cell carcinoma. Tumour Biol. 2014 Dec;35(12):11977-84. doi: 10.1007/s13277-014-2494-8. Epub 2014 Aug 21. PubMed 25142232 ↗
  • Beije N, Jager A, Sleijfer S. Circulating tumor cell enumeration by the CellSearch system: the clinician's guide to breast cancer treatment? Cancer Treat Rev. 2015 Feb;41(2):144-50. doi: 10.1016/j.ctrv.2014.12.008. Epub 2014 Dec 23. PubMed 25542852 ↗
  • Graham TR, Zhau HE, Odero-Marah VA, Osunkoya AO, Kimbro KS, Tighiouart M, Liu T, Simons JW, O'Regan RM. Insulin-like growth factor-I-dependent up-regulation of ZEB1 drives epithelial-to-mesenchymal transition in human prostate cancer cells. Cancer Res. 2008 Apr 1;68(7):2479-88. doi: 10.1158/0008-5472.CAN-07-2559. Erratum In: Cancer Res. 2008 May 15;68(10):4012. PubMed 18381457 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02431078
Lead sponsor
wei bo
Responsible party
wei bo (Vice Director of the general surgery department, Chinese PLA General Hospital, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Apr 30, 2015
Start date
Jun 2015
Primary completion
Jun 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jul 29, 2015

Study contacts

Wei bo, MD
study chair · Vice director of the general surgery department, Chinese PLA General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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