UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Autoantibody analysis in patients with immunological diseases
Title of the study (Brief title)	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	Yasuhiko Itoh
Organization	Nippon Medical School
Division name	Department of Pediatrics
Address	1-1-5 Sendagi, Bunkyo City, Tokyo, Japan
TEL	03-3822-2131
Email	yasuhiko@nms.ac.jp

Public contact
Name of contact person	Yasuhiko Itoh
Organization	Nippon Medical School
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000000707