UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019760 |
|---|---|
| Receipt number | R000022816 |
| Scientific Title | Functional analysis of intestinal fibroblast during fibrosis and canceration process |
| Date of disclosure of the study information | 2015/11/13 |
| Last modified on | 2015/11/12 09:58:02 |
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Basic information
Public title
Functional analysis of intestinal fibroblast during fibrosis and canceration process
Acronym
Functional analysis of intestinal fibroblast
Scientific Title
Functional analysis of intestinal fibroblast during fibrosis and canceration process
Scientific Title:Acronym
Functional analysis of intestinal fibroblast
Region
| Japan |
Condition
Condition
scirrhous stomach cancer, postoperative stenosis, fibrotic stenosis in Crohn's disease,
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
investigation of molecular target for tissue fibrosis treatment
Basic objectives2
Others
Basic objectives -Others
Functional analysis of fibroblast during fibrosis process
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of before and after anti-fibrotic treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
biopsy sampling from stenotic area before steroid treatment
Interventions/Control_2
biopsy sampling from stenotic area after steroid treatment
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
older than 20 years, without dysfunction of major organ
Key exclusion criteria
younger than 20 years, with dysfunction of major organ
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rin Kurahara |
Organization
Fukuoka university, school of medicine
Division name
Department of physiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka
TEL
0928011011
hailin@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rin Kurahara |
Organization
Fukuoka university, school of medicine
Division name
Department of physiology
Zip code
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
hailin@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | 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
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022816
