UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028720 |
|---|---|
| Receipt number | R000032869 |
| Scientific Title | Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases. |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2021/08/20 13:52:18 |
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Basic information
Public title
Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Acronym
Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Scientific Title
Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Scientific Title:Acronym
Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Region
| Japan |
Condition
Condition
connective tissue disease, healthy volunteers
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Basic objectives2
Others
Basic objectives -Others
The purpose of the present study is to elucidate association between the pathogenic mechanism and histone methylations of peripheral white blood cells in connective tissue diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of histone methylation of peripheral white blood cells in patients with connective tissue diseases and healthy volunteers.
Key secondary outcomes
The factors regulated by histone methylations.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Blood examination
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
1) Patients and healthy volunteers at least 20 years old at enrollment
2) Patients and healthy volunteers who have given their written informed consent
Key exclusion criteria
1) Pregnant females
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Mimura |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL
049-276-1462
toshim@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshihide |
| Middle name | |
| Last name | Mimura |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL
049-276-1462
Homepage URL
toshim@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma, Saitama 350-0495, Japan
Tel
049-276-1354
hirb@saitama-med.ac.jp
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
| 2017 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032869
| Research Plan | |
|---|---|
| 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 |
