UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011706 |
|---|---|
| Receipt number | R000013686 |
| Scientific Title | Establish of the diagnosis method by flow cytometric analysis of Coombs negative AIHA |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/03/22 09:25:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establish of the diagnosis method by flow cytometric analysis of Coombs negative AIHA
Acronym
The diagnosis method of Coombs negative AIHA
Scientific Title
Establish of the diagnosis method by flow cytometric analysis of Coombs negative AIHA
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yamashiro |
Organization
Yamaguchi unversity graduate school of medicine
Division name
Faculty of helthe sciences
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2863
yamasiro@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yamashiro |
Organization
Yamaguchi unversity graduate school of medicine
Division name
Faculty of helthe sciences
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2863
Homepage URL
yamasiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi unversity graduate school of medicine
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 19 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013686
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
