UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004038 |
|---|---|
| Receipt number | R000004858 |
| Scientific Title | Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases |
| Date of disclosure of the study information | 2010/08/12 |
| Last modified on | 2017/03/01 10:55:22 |
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Basic information
Public title
Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases
Acronym
Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases
Scientific Title
Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases
Scientific Title:Acronym
Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases
Region
| Japan |
Condition
Condition
blood, immune disorders and circulatory diseases
Classification by specialty
| Cardiology | Hematology and clinical oncology | Clinical immunology |
| Vascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to determine significance of the neutrophil myeloperoxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases, and to make use of MPXI for early diagnosis and prognostic estimate of these diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Correlation between inflammatory marker and MPXI in inflammatory disorder or immune disorder
2)Correlation between morphologic diagnosis using a smear observation and MPXI in leukemia, MDS, or MPO deficiency
3) Correlation between Troponin one or CK-MB and MPXI in ischemic heart disease
Key secondary outcomes
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
| 10 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had a diagnosis of blood disorder, immune disorder or circulatory disease by a biochemical test, an immunologic test and a hematologic test including a smear examination
Key exclusion criteria
1)Inappropriate patients for this study judged by the diagnosticians
2)Patients cannot agree to participate in this trial.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Horie |
Organization
Kobe University Graduate School of Health Sciences
Division name
Division of Medical Biophysics
Zip code
Address
7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
078-796-4558
horie@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yonezawa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Division of Medical Biophysics
Zip code
Address
7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
078-929-1151
Homepage URL
k.yonezawa717@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Cancer Center
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
| 2010 | Year | 08 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the correlation between MPXI and various clinical laboratory data in detail.
Management information
Registered date
| 2010 | Year | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004858
