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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024585
Receipt No. R000028297
Scientific Title The investication of prolifelative factors in gastric/colonic ESD ulcer.
Date of disclosure of the study information 2016/10/27
Last modified on 2016/10/27

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Basic information
Public title The investication of prolifelative factors in gastric/colonic ESD ulcer.
Acronym The investication of prolifelative factors in gastric/colonic ESD ulcer
Scientific Title The investication of prolifelative factors in gastric/colonic ESD ulcer.
Scientific Title:Acronym The investication of prolifelative factors in gastric/colonic ESD ulcer
Region
Japan

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

Objectives
Narrative objectives1 To invetigate the proloferative factors of gastric/colonic ESD ulcer.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The quantity of EGF,HGF,FGF,VEG,GM-CSF)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 to perform biopsy from the edge of the ESD ulcer 3 months after performing ESD.
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who underwent gastric/colonic ESD in the department of gasroenterology in Chiba university.
Key exclusion criteria no exclusion criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba niversity
Division name Department of gastroenterology iChiba niversity
Zip code
Address 1 8 1 Inohana Cyuo ward Chiba city
TEL 043-222-7171
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 and neohrology
Zip code
Address 1 8 1 Inohana Cyuo ward Chiba city
TEL 043-222-7171
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Department of fastroenterology in Chiba university
Institute
Department

Funding Source
Organization Department of fastroenterology in Chiba university
Organization
Division
Category of Funding Organization Other
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
2016 Year 10 Month 27 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 09 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 performing biopsy from the edge of the ulcer post ESD 3 months after performing ESD.Then we perform genetic analysis.

Management information
Registered date
2016 Year 10 Month 27 Day
Last modified on
2016 Year 10 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028297

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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