UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000611 |
|---|---|
| Receipt number | R000000707 |
| Scientific Title | Autoantibody analysis in patients with immunological diseases |
| Date of disclosure of the study information | 2008/04/24 |
| Last modified on | 2016/08/26 09:19:05 |
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Basic information
Public title
Autoantibody analysis in patients with immunological diseases
Acronym
autoantibodies in immunological diseases
Scientific Title
Autoantibody analysis in patients with immunological diseases
Scientific Title:Acronym
autoantibodies in immunological diseases
Region
| Japan |
Condition
Condition
immunological diseases
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of autoantibody profile in patients with various immunological diseases
Basic objectives2
Others
Basic objectives -Others
To detect all the autoantibodies, including unknown or extremely rare ones, in patients with various immunological diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Describing all the autoantibodies in individual patient sera
Key secondary outcomes
Contribution to understanding of pathophysiology in each disease
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
| 0 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
immunological disease
Key exclusion criteria
non-immunological diseases
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Itoh |
Organization
Nippon Medical School
Division name
Department of Pediatrics
Zip code
Address
1-1-5 Sendagi, Bunkyo City, Tokyo, Japan
TEL
03-3822-2131
yasuhiko@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Itoh |
Organization
Nippon Medical School
Division name
Department of Pediatrics
Zip code
Address
1-1-5 Sendagi, Bunkyo City, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
yasuhiko@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
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
日本医科大学付属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 24 | 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
1. The target antigen of anti-Sa antibodies was identified to be lens epithelium derived growth factor / transcription coactivator p75 (LEDGF/p75).
2. Anti-Sa strongly correlates with fatigue, as most of patients with chronic fatigue syndrome have this autoantibody.
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Autoantibodies in patient sera are analyzed mainly by using Western immunoblot with HeLa cell extract as antigen sourse.
Management information
Registered date
| 2007 | Year | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000707
