UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the neutrophil myelo- peroxidase index (MPXI) with blood disorders, immune disorders or circulatory diseases
Title of the study (Brief title)	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	Osamu Horie
Organization	Kobe University Graduate School of Health Sciences
Division name	Division of Medical Biophysics
Address	7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL	078-796-4558
Email	horie@kobe-u.ac.jp

Public contact
Name of contact person	Kenji Yonezawa
Organization	Kobe University Graduate School of Health Sciences
Division name	Division of Medical Biophysics
Address	7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL	078-929-1151
Homepage URL
Email	k.yonezawa717@gmail.com

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004858