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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004004
Receipt No. R000004384
Scientific Title The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Date of disclosure of the study information 2010/08/06
Last modified on 2017/11/17

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Basic information
Public title The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Acronym The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Scientific Title The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Scientific Title:Acronym The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Region
Japan North America

Condition
Condition gastric cancer,esophageal adenocarcinoma
Barrett's esophageal epithelium
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify the genes causing elongation of Barrett's esophageal epithelium and subsequent development of gastric cancer after endoscopic resection and H. pylori eradication
Basic objectives2 Others
Basic objectives -Others To identify the risk markers related with elongation of Barrett's esophageal epithelium and subsequent development of gastric cancer after endoscopic resection and H. pylori eradication
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Genes expressions including the micro RNA in the patients with Barrett's esophageal epithelium or gastric cancer after endoscopic resection before and after H. pylori eradication
Key secondary outcomes comparison of gene expression in the Barrett epithelium between American and Japanese

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 H. pylori eradication
triple therapy 1 week
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 The patients with Barrett's esophageal epithelium and the patietns with endoscopic resection for early gastric cacner and H. pylori eradication
Key exclusion criteria taking NSAIDs
history of gastrectomy or eradication
haemorrhagic diseases
insulin dependent diabetes mellitus cirrhosis
renal failure
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko shiotani
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577,Matsushima,Kurashiki,Okayama
TEL 81864624444
Email shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko shiotani
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577,Matsushima,Kurashiki,Okayama
TEL 81-86-462-1111
Homepage URL
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization Government offices of other countries
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
2010 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 06 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004384

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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