Stomach NeoplasmsNCT02431078
The Expression of ZEB1 in CTCs Associated With Metastasis and Recurrence for Gastric Cancer
An observational study of Stomach Neoplasms, run by wei bo.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Routine comprehensive treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximate 150 consecutive patients with gastric cancer and CTCS(+) will be enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Stomach Neoplasms
- Being tested
- Routine comprehensive treatment
- Keywords
- CTCs, ZEB1, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine comprehensive treatmentProcedure or surgery
Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Routine comprehensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
three-year disease free survival rate
Measured: Up to 3 years post-operative
Secondary outcomes (3)
three-year overall survival rate
Measured: Up to 3 years post-operative
metastasis and recurrence rate
Measured: Up to 3 years post-operative
baseline detection of ZEB1 expression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wei bo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wei bo, Chinese PLA General Hospital
- Investigators
- Wei bo, MD, Study chair, Vice director of the general surgery department, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431078
- Sponsor's protocol ID
- experiment20152018
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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 25489583Toss 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 25489582Okugawa 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 22095522Yabusaki 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 25798282Jia 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 22466758Yang 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 25142232Beije 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 25542852Graham 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.
PubMed 18381457
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02431078
- Acronym / sponsor ID
- experiment20152018
- Conditions
- Stomach Neoplasms
- Keywords
- CTCs, ZEB1, gastric cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- wei boUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEB1 high-expression group | – | Procedure: Routine comprehensive treatmentParticipants 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. |
| ZEB1 low-expression group | – | Procedure: Routine comprehensive treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximate 150 consecutive patients with gastric cancer and CTCS(+) will be enrolled in this study.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine comprehensive treatmentRadical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy | Procedure or surgery | ZEB1 high-expression group, ZEB1 low-expression group |
Primary outcome
three-year disease free survival rate
Time frame: Up to 3 years post-operative
3 secondary outcomes
three-year overall survival rate
Time frame: Up to 3 years post-operative
metastasis and recurrence rate
Time frame: Up to 3 years post-operative
baseline detection of ZEB1 expression
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 25489583Barriere 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.
- Background: PubMed 25489582Toss 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.
- Background: PubMed 22095522Okugawa 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.
- Background: PubMed 25798282Yabusaki 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.
- Background: PubMed 22466758Jia 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.
- Background: PubMed 25142232Yang 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.
- Background: PubMed 25542852Beije 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.
- Background: PubMed 18381457Graham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei bo, MD study chair
Vice director of the general surgery department, Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms, run by wei bo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
three-year disease free survival rate (time frame: Up to 3 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431078, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.