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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013847
Receipt No. 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

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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
Email 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
Email tomoyosi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016088

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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