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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008655
Receipt No. 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 2018/02/13

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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
Email 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
Email akikosad@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
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

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
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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