UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010651 |
|---|---|
| Receipt number | 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 16:57:20 |
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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
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
kitawaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012419
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
