UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017035 |
|---|---|
| Receipt number | 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 15:02:38 |
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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
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
itot@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University, First Dept. Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019755
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
