UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013847 |
|---|---|
| Receipt number | R000016088 |
| Scientific Title | Assessment of the utility of MAIT cells as a biomarker for inflammatory bowel diseases |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2016/04/30 15:53:29 |
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Basic information
Public title
Assessment of the utility of MAIT cells as a biomarker for inflammatory bowel diseases
Acronym
A study of MAIT cells as a biomarker in inflammatory bowel diseases
Scientific Title
Assessment of the utility of MAIT cells as a biomarker for inflammatory bowel diseases
Scientific Title:Acronym
A study of MAIT cells as a biomarker in inflammatory bowel diseases
Region
| Japan |
Condition
Condition
Inflammatory bowel diseases
Classification by specialty
| Medicine in general | Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study correlation between MAIT cells and the disease activity by counting MAIT cells in peripheral blood, and reveal the possibility of MAIT cells as a biomarker in inflammatory bowel diseases.
Basic objectives2
Others
Basic objectives -Others
To study correlation between MAIT cells and the disease activity by counting MAIT cells in colon tissues.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observe symptoms or endoscopic findings, and examine by comparing the numbers of MAIT cells in peripheral blood and colon tissues.
Key secondary outcomes
Base
Study type
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
sampling
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
IBD patients(mild-severe)
Patiens consent to the study.
Key exclusion criteria
1.Severe complecations.
2.Have other autoimmune disorders.
3.Using antithrombotic drugs.
4.Pregnant woman.
5.Judged to be inappropriate to the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyouku Tokyo
TEL
03-5802-1060
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyoshi Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyouku Tokyo
TEL
03-5802-1060
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
| 2014 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 23 | 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
| 2014 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016088
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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