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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010651
Receipt No. R000012419
Scientific Title Comprehensive analysis of protein phosphorylation in immune cells from patients under the administration of the tyrosine kinase inhibitor dasatinib
Date of disclosure of the study information 2013/06/01
Last modified on 2013/05/06

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Basic information
Public title Comprehensive analysis of protein phosphorylation in immune cells from patients under the administration of the tyrosine kinase inhibitor dasatinib
Acronym Comprehensive analysis of the immunomodulatory effects of dasatinib
Scientific Title Comprehensive analysis of protein phosphorylation in immune cells from patients under the administration of the tyrosine kinase inhibitor dasatinib
Scientific Title:Acronym Comprehensive analysis of the immunomodulatory effects of dasatinib
Region
Japan

Condition
Condition chronic myelogenous leukemia
Philadelphia chromosome-positive acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is to clarify the mechanisms by which cytotoxic lymphocytes increase in patients taking the tyrosine kinase inhibitor dasatinib, by analyzing protein phosphorylation patterns in leukocytes in blood using flow cytometry.
Basic objectives2 Others
Basic objectives -Others N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of each leukocyte fraction in blood
Phosphorylation of intracellular proteins in each leukocyte fraction
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients of CML or Ph-positive ALL who are 20 years of age or more
2) Patients who are going to take or are taking dasatinib, imatinib, or nilotinib
3) Patients from whom informed consent has been obtained using documents
Key exclusion criteria None
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Takaori
Organization Graduate School of Medicine, Kyoto University
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Kitawaki
Organization Graduate School of Medicine, Kyoto University
Division name Department of Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Email kitawaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology
Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Bristol-Myers Squibb Co.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyze the profiles of protein phosphorylation in each leukocyte fraction from patients with Ph-positive leukemia taking dasatinib

Management information
Registered date
2013 Year 05 Month 06 Day
Last modified on
2013 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012419

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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