UMIN-CTR Clinical Trial

Basic information
Public title	Study for biomarkers and molecular pathophysiology of Myeloproliferative disorders with eosinophilia.
Acronym	Study for biomarkers and molecular pathophysiology of Myeloproliferative disorders with eosinophilia.
Scientific Title	Study for biomarkers and molecular pathophysiology of Myeloproliferative disorders with eosinophilia.
Scientific Title:Acronym	Study for biomarkers and molecular pathophysiology of Myeloproliferative disorders with eosinophilia.
Region	Japan

Condition
Condition	Hypereosinophilic syndrome, chronic eosinophilic leukemia, idiopathic eosinophilia.
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To elucidate molecular pathophysiology of Myeloproliferative disorders with eosinophilia and to find their diagnostic biomarkers. In addition to new data, partially utilize existing data gained from the studies below (1, 2). 1. A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome. (UMIN000008653) 2. Study of abnormal activity and mutation of tyrosine kinases in Hypereosinophilic syndrome. (UMIN000008655)
Basic objectives2	Others
Basic objectives -Others	To evaluate quality and quantity of phosphorylated protein in the blood cells.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Exploration of disease specific biomarkers in Myeloproliferative disorders with eosinophilia.
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
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Clinically diagnosed or suspected cases of Myeloproliferative disorders with eosinophilia. Healthy volunteer.
Key exclusion criteria	Definite diagnosed secondary eosinophilia.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshio Katayama
Organization	Kobe university hospital
Division name	Division of Hematology
Zip code
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-6912
Email	katayama@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akiko Sada
Organization	Department of Medicine, Kobe University Graduate School of Medicine
Division name	Division of Hematology
Zip code
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	078-382-5111(6912)
Homepage URL
Email	akikosad@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Medical School Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	好酸球増多症を扱う全国の医療機関が参加する予定/Nationwide Medical Institutions where physicians take care of HES/CEL in Japan

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 15 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
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Results Delayed
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Baseline Characteristics
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 15 Day
Date of IRB	2012 Year 12 Month 03 Day
Anticipated trial start date	2012 Year 12 Month 15 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	Retrospective study We will describe the findings of observation in future.

Management information
Registered date	2012 Year 10 Month 18 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010715