NCT02431078

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 29, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

April 20, 2015

Last Update Submit

July 28, 2015

Conditions

Stomach Neoplasms

Keywords

CTCsZEB1gastric cancer

Outcome Measures

Primary Outcomes (1)

  • three-year disease free survival rate

    Up to 3 years post-operative

Secondary Outcomes (3)

  • 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

Study Arms (2)

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

Routine comprehensive treatmentPROCEDURE

Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy

ZEB1 high-expression groupZEB1 low-expression group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximate 150 consecutive patients with gastric cancer and CTCS(+) will be enrolled in this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25489583BACKGROUND

  • 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.

    PMID: 25489582BACKGROUND

  • 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.

    PMID: 22095522BACKGROUND

  • 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.

    PMID: 25798282BACKGROUND

  • 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.

    PMID: 22466758BACKGROUND

  • 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.

    PMID: 25142232BACKGROUND

  • 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.

    PMID: 25542852BACKGROUND

  • 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.

    PMID: 18381457BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Circulating Tumor Cells

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei bo, MD

    Vice director of the general surgery department, Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director of the general surgery department, Chinese PLA General Hospital

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 30, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

July 29, 2015

Record last verified: 2015-04