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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001057
Receipt No. R000001271
Scientific Title Surveillance for early gastric cancer after endoscopic submucosal dissection and H.pylori eradication.
Date of disclosure of the study information 2008/02/27
Last modified on 2015/09/02

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Basic information
Public title Surveillance for early gastric cancer after endoscopic submucosal dissection and H.pylori eradication.
Acronym Surveillance for early gastric cancer after endoscopic submucosal dissection.
Scientific Title Surveillance for early gastric cancer after endoscopic submucosal dissection and H.pylori eradication.
Scientific Title:Acronym Surveillance for early gastric cancer after endoscopic submucosal dissection.
Region
Japan

Condition
Condition Early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to elucidate the molecular mechanism of gastric carcinogenesis and develop the new therapeutic approach of gastric cancer.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence of gastric cancer after endoscopic submucosal dissection and Aberrant DNA methylation and aberrant expression of microRNAs, DNA, and proteins, including CD44v9, CagA and stemness-related factors, in gastric tumors and in background gastric mucosa such as atrophic and metaplastic mucosa
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were diagnosed as early gastric cancer and are considered as the indication of endoscopic submucosal dissection.
Key exclusion criteria Patients who have anticoagulant therapy.
Patients who had total gastrectomy during the course observation.
Patients who do not respond to 2nd eradication thrapy of H.pylori.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Suzuki
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3914
Email hsuzuki@a6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Suzuki
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3914
Homepage URL
Email hsuzuki@a6.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology, Keio University, School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/bjc/journal/v109/n2/full/bjc2013314a.html
Number of participants that the trial has enrolled
Results
BACKGROUND: 
Multiple early gastric cancers (EGCs) may develop in 6-14% of patients even after achieving curative endoscopic submucosal dissection (ESD); however, a useful biomarker for predicting recurrence is not available. The present study investigated whether the expression of CD44 variant 9 (CD44v9), a functional cancer stem cell marker, in the primary gastric cancer tissue represents an indicator of recurrence.

METHODS: 
Eighty-eight patients who underwent ESD for EGC from 2008 to 2010 were enrolled and monitored for recurrence for 3 years. The expression levels of CD44v9 in the tissue of initial EGCs were evaluated by immunohistochemistry, and the recurrence rate was compared between CD44v9-positive and CD44v9-negative groups. The mucin phenotype and expression of microRNA-21 (miR-21) and programmed cell death protein 4 (PDCD4) were also analysed.

RESULTS: 
The recurrence rate of EGC was significantly higher in the CD44v9-positive group than in the CD44v9-negative group (hazard ratio (HR), 21.8; 95% confidence interval (CI), 5.71-83.1). However, mucin phenotypes and the expression of miR-21 and PDCD4 did not predict recurrence after ESD. Meanwhile, grade of gastric atrophy was also identified as a significant marker of multiple recurrence (HR, 4.95; 95% CI, 1.30-18.8).

CONCLUSION: 
CD44 variant 9 expression represents a potential predictive marker for recurrence in EGC.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2016 Year 11 Month 30 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information Recurrence of gastric cancer after endoscopic submucosal dissection
Aberrant DNA methylation and aberrant expression of microRNAs and proteins, including CD44v9 and CagA, in gastric tumors and epithelial tissues

MicroRNAs (miRNAs) are small noncoding RNAs that function as endogenous silencers of target genes and play critical roles during carcinogenesis. The selective cyclooxygenase-2 (COX-2) inhibitor celecoxib has been highlighted as a potential drug for treatment of gastrointestinal tumors. The aim of this study was to investigate the role of miRNAs in gastric carcinogenesis and the feasibility of a new therapeutic approach for gastric cancer. miRNA expression profiles were examined in 53 gastric tumors including gastric adenomas (atypical epithelia), early gastric cancers and advanced gastric cancers and in gastric cancer cells treated with celecoxib. miRNA microarray analysis revealed that miR-29c was significantly downregulated in gastric cancer tissues relative to nontumor gastric mucosae. miR-29c was significantly activated by celecoxib in gastric cancer cells. Downregulation of miR-29c was associated with progression of gastric cancer and was more prominent in advanced gastric cancers than in gastric adenomas and early gastric cancer. In addition, expression of the oncogene Mcl-1, a target of miR-29c, was significantly increased in gastric cancer tissues relative to nontumor gastric mucosae. Activation of miR-29c by celecoxib induced suppression of Mcl-1 and apoptosis in gastric cancer cells. These results suggest that downregulation of the tumor suppressor miR-29c plays critical roles in the progression of gastric cancer. Selective COX-2 inhibitors may have clinical promise for the treatment of gastric cancer via restoration of miR-29c.

Management information
Registered date
2008 Year 02 Month 27 Day
Last modified on
2015 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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