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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010092
Receipt No. R000011821
Scientific Title Analysis of gene expression of gastric mucosa regeneration in artificial gastric ulcer after endoscopic submucosal dissection (ESD)
Date of disclosure of the study information 2013/02/21
Last modified on 2014/08/21

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Basic information
Public title Analysis of gene expression of gastric mucosa regeneration in artificial gastric ulcer after endoscopic submucosal dissection (ESD)
Acronym Analysis of gene expression of gastric mucosa regeneration in artificial gastric ulcer
Scientific Title Analysis of gene expression of gastric mucosa regeneration in artificial gastric ulcer after endoscopic submucosal dissection (ESD)
Scientific Title:Acronym Analysis of gene expression of gastric mucosa regeneration in artificial gastric ulcer
Region
Japan

Condition
Condition Gastric Ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal gene expressions associated with gastric mucosa regenerationfor by comparison of gene expression in surrounding mucosa of ESD-induced artificial gastric ulcers with in normal gastric mucosa.
Basic objectives2 Others
Basic objectives -Others Gene expression analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PCR array analysis, Real-time PCR analysis
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 recieved ESD for gastric tumor
Key exclusion criteria Patients evaluated incompetent by doctors in attendance
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL 043-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Arai
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL 043-226-2083
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
2013 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24224878
Number of participants that the trial has enrolled
Results
Expression of Shh was correlated with the speed of gastric ulcer healing, promoting the regeneration of gastric mucosa.
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
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of gene expression of gastric mucosa after ESD

Management information
Registered date
2013 Year 02 Month 21 Day
Last modified on
2014 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011821

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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