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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000611
Receipt No. 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

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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
Email 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
Email yasuhiko@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000707

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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