UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009140 |
|---|---|
| Receipt number | R000010715 |
| Scientific Title | Study for biomarkers and molecular pathophysiology of Myeloproliferative disorders with eosinophilia. |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2021/04/30 14:15:27 |
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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
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
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
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
akikosad@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010715
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
