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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017035
Receipt No. R000019755
Scientific Title Analysis of Dendritic cells in blood and focal area in patients with refractory inflammatory diseases
Date of disclosure of the study information 2015/04/03
Last modified on 2015/04/03

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Basic information
Public title Analysis of Dendritic cells in blood and focal area in patients with refractory inflammatory diseases
Acronym Dendritic cell analysis in refractory inflammatory diseases
Scientific Title Analysis of Dendritic cells in blood and focal area in patients with refractory inflammatory diseases
Scientific Title:Acronym Dendritic cell analysis in refractory inflammatory diseases
Region
Japan

Condition
Condition Refractory inflammatory disease (interstitial pneumonia, bronchial asthma, Crohn's disease, ulcerative colitis, Behcet's disease)
Classification by specialty
Medicine in general Gastroenterology Pneumology
Clinical immunology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess pathogenesis of refractory inflammatory diseases and identify subset of relevant dendritic cell subset and immune cells by measuring serum cytokine and expression level of dendritic cell-associated markers (chemokine XCR1, TLR families, i.e.) in each tissue (peripheral blood, lung tissue, gastrointestinal tissue) of human inflammatory diseases.
Basic objectives2 Others
Basic objectives -Others elucidation of pathogenesis in inflammatory diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. ELISA method for serum and HMGB1, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL-13, IL-17, IL-15, IL-18, IL -21, IL-22, IFN-alpha,IFN-gamma,TNF
2. mononuclear cell fraction, dendritic cells, immune cell markers by flow cytometry (CD11c, CD14, BDCA1, BDCA2, BDCA3, BDCA4, OX40L, ICOSL, GITRL, and analyzed by staining 4-1BBL, RANKL, TLR)
3. sections during tissue biopsy and surgical resection; staining and analysis using an antibody XCR1 and TLR family antibodies.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients suffering from interstitial pneumonia, bronchial asthma, inflammatory bowel disease was admitted to hospital (Crohn's disease, ulcerative colitis, Behcet's disease) in Kansai Medical University Hirakata hospital.
Key exclusion criteria 1.minors and adults with no judgment ability
2.patients whom physician has determined that inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Ito
Organization Kansai Medical University
Division name First Dept. Internal Medicine
Zip code
Address 2-5-1, Shinmachi, Hirakata city, Osaka, Japan
TEL 81-72-804-2425
Email itot@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoki Ito
Organization Kansai Medical University
Division name First Dept. Internal Medicine
Zip code
Address 2-5-1, Shinmachi, Hirakata city, Osaka, Japan
TEL 81-72-804-2425
Homepage URL
Email itot@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University, First Dept. Internal Medicine
Institute
Department

Funding Source
Organization Kansai Medical University, First Dept. Internal Medicine
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
2015 Year 04 Month 03 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
2015 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before start of the study

Management information
Registered date
2015 Year 04 Month 03 Day
Last modified on
2015 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019755

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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