UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024585 |
|---|---|
| Receipt number | 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 13:25:39 |
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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
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
araim-cib@umin.ac.jp
Sponsor or person
Institute
Department of fastroenterology in Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028297
