Clinical trial · Observational

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

The Expression of Zinc Finger E-Box Binding Homeobox 1 (ZEB1) in Circulating Tumor Cells(CTCs) Associated With Metastasis and Recurrence for Gastric Cancer

NCT02431078CI-TRIAL-00018704unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Stomach Neoplasms	Gastric Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Routine comprehensive treatment	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
ZEB1 high-expression group
description
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.
interventionNames
1. Procedure: Routine comprehensive treatment
label
ZEB1 low-expression group
description
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.
interventionNames
1. Procedure: Routine comprehensive treatment

Primary outcomes (1)

measure
three-year disease free survival rate
timeFrame
Up to 3 years post-operative

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (8)

BACKGROUNDBarriere 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 25489583
BACKGROUNDToss 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 25489582
BACKGROUNDOkugawa 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 22095522
BACKGROUNDYabusaki 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 25798282
BACKGROUNDJia 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 22466758
BACKGROUNDYang 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 25142232
BACKGROUNDBeije 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.