UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015409 |
|---|---|
| Receipt number | R000017875 |
| Scientific Title | molecular based analysis and novel therapies development of chronic myelocytic leukemia |
| Date of disclosure of the study information | 2014/10/14 |
| Last modified on | 2014/10/09 09:45:59 |
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Basic information
Public title
molecular based analysis and novel therapies development of chronic myelocytic leukemia
Acronym
molecular based analysis and novel therapies development of chronic myelocytic leukemia
Scientific Title
molecular based analysis and novel therapies development of chronic myelocytic leukemia
Scientific Title:Acronym
molecular based analysis and novel therapies development of chronic myelocytic leukemia
Region
| Japan |
Condition
Condition
chronic myelocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
molecular based analysis and novel therapies development of chronic myelocytic leukemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
copy number ob BCR-ABL in PCR
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic myelocytic leukemia patient who are treated by Keio University
Key exclusion criteria
1 Can not consent in writing
2 physician deems disqualify
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
okamoto@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiki Karigane |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
karigane@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine, Division of Hematology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for scientific research
Organization
Division
Category of Funding 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
| 2014 | Year | 10 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The activity of chronic myelocytic leukemia is evaluated with bone marrow examination every six months in Keio University Hospital. On every examination, the followings will be assessed: cell biological, molecular and metabolic analysis. Finally, we evaluate the correlation between analysis and chronic myelocytic leukemia activity (the copy number of BCR-ABL in PCR).
Management information
Registered date
| 2014 | Year | 10 | Month | 10 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
