UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020127 |
|---|---|
| Receipt number | R000023252 |
| Scientific Title | The pharmacogenomics approach about MTX-induced leukoencephalopathy |
| Date of disclosure of the study information | 2015/12/09 |
| Last modified on | 2015/12/09 14:13:01 |
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Basic information
Public title
The pharmacogenomics approach about MTX-induced leukoencephalopathy
Acronym
The pharmacogenomics of MTX-induced leukoencephalopathy
Scientific Title
The pharmacogenomics approach about MTX-induced leukoencephalopathy
Scientific Title:Acronym
The pharmacogenomics of MTX-induced leukoencephalopathy
Region
| Japan |
Condition
Condition
leukoencephalopthy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigated the effect of gene and clinical factor about MTX-induced leukoencephalopathy
Basic objectives2
Others
Basic objectives -Others
adverse event
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association MTX-induced leukoencephalopathy and gene after chemotherapy
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
| 0 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who were investigated CNS by MRI after chemotherapy or before bone marrow transplantation
Key exclusion criteria
Not investigated CNS by MRI
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakatsu Yanagimachi |
Organization
Yokohama city university
Division name
Department of Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
t156046c@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsujimoto Shinichi |
Organization
Yokohama city university
Division name
Department of Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
Homepage URL
t156046c@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
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
| 2015 | Year | 12 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
We investigate chart about leukoencepahlopathy and clinical data
Management information
Registered date
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2015 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023252
