UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020356 |
|---|---|
| Receipt number | R000023502 |
| Scientific Title | Analysis of T-cell and NK-cell immunity in chronic myelogenous leukemia |
| Date of disclosure of the study information | 2015/12/26 |
| Last modified on | 2015/12/28 22:36:48 |
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Basic information
Public title
Analysis of T-cell and NK-cell immunity in chronic myelogenous leukemia
Acronym
Immunological analysis in CML
Scientific Title
Analysis of T-cell and NK-cell immunity in chronic myelogenous leukemia
Scientific Title:Acronym
Immunological analysis in CML
Region
| Japan |
Condition
Condition
Chronic Myelogenous Leukemia (CML)
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Verify whether the immunological polymorphic factors including HLA/KIR/MICA/NKG2D impact the efficacy of tyrosine kinase inhibitors (TKIs) in chronic myelogenous leukemia (CML) patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of TKIs in CML patients (Measurement of bcr-abl fusion gene)
Key secondary outcomes
T cell diversity and NK cell polymorphisms
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic myelogenous leukemia (CML) patients who take or will take TKIs.
Key exclusion criteria
Subjects who are determined to be unsuitable for enrolled in the present study by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kimura |
Organization
Saga University School of Medicine
Division name
Hematology, Respiratory Medicine and Oncology
Zip code
Address
5-1-1 Nabeshima, Saga Japan
TEL
0952-31-6511
shkimu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takero Shindo |
Organization
Saga University School of Medicine
Division name
Hematology, Respiratory Medicine and Oncology
Zip code
Address
5-1-1 Nabeshima, Saga Japan
TEL
0952-31-6511
Homepage URL
takeros@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Donation money for research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
佐賀大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center observational study (case-control study)
Eligible subjects are CML patients who take or will take TKI, and visit Saga University Hospital between 12/26/2015 and 3/31/2018.
The patients are assigned to two groups, good responders and poor responders. The differences between the two groups are to be analyzed as for immunological polymorphisms including HLA/KIR/NKG2D/MICA and T cell diversity before and after TKI therapy.
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023502
