UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008655 |
|---|---|
| Receipt number | R000010169 |
| Scientific Title | Study of abnormal avtivity and mutation of tyrosine kinases in Hypereosinophilic syndrome. |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2021/04/30 14:24:45 |
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Basic information
Public title
Study of abnormal avtivity and mutation of tyrosine kinases in Hypereosinophilic syndrome.
Acronym
Study of abnormal tyrosine kinase expression in HES.
Scientific Title
Study of abnormal avtivity and mutation of tyrosine kinases in Hypereosinophilic syndrome.
Scientific Title:Acronym
Study of abnormal tyrosine kinase expression in HES.
Region
| Japan |
Condition
Condition
Hypereosinophilic syndrome,chronic eosinophilic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Study of abnormal tyrosine kinase activities in Imatinib-refractory HES/CEL
Basic objectives2
Others
Basic objectives -Others
To explore biomarkers in diagnosis and Imatinib treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploration of novel biomarkers in HES/CEL
Key secondary outcomes
Function analysis of the newly explored biomakers
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
Imatinib treated HES/CEL without F/P fusion gene, and Imatinib resistant CEL with F/P fusion gene.
Key exclusion criteria
Corticosteroid or Antiallergic drug effective HES
Target sample size
30
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
Kobe University Graduate School of Medicine
Division name
Division of Hematology,Department of Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6912
Homepage URL
akikosad@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
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 | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/17701174
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
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
This stydy is related to the clinical trial registered in UMIN(UMIN000008653;A clinical trial to establish the proper diagnosis and therapy of Hypereosinophilic syndrome).
Management information
Registered date
| 2012 | Year | 08 | Month | 09 | 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=R000010169
