UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establish of the diagnosis method by flow cytometric analysis of Coombs negative AIHA
Title of the study (Brief title)	The diagnosis method of Coombs negative AIHA
Region	Japan

Condition
Condition	Coombs negative AIHA
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establish of daignosis method
Basic objectives2	Others
Basic objectives -Others	Non RI method
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison with the RI data
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Take a blood from Coombs-negative group (normal group)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Coombs negative samples and positive samples (normal group)
Key exclusion criteria	The case of high IgM and IgG values ​​in the normal group
Target sample size	200

Research contact person
Name of lead principal investigator	Yasuhiro Yamashiro
Organization	Yamaguchi unversity graduate school of medicine
Division name	Faculty of helthe sciences
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2863
Email	yamasiro@yamaguchi-u.ac.jp

Public contact
Name of contact person	Yasuhiro Yamashiro
Organization	Yamaguchi unversity graduate school of medicine
Division name	Faculty of helthe sciences
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2863
Homepage URL
Email	yamasiro@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi unversity graduate school of medicine
Institute
Department

Funding Source
Organization	Yamaguchi unversity graduate school of medicine
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 19 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 11 Day
Last modified on	2017 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013686