UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008715 |
|---|---|
| Receipt number | R000010237 |
| Scientific Title | Examination of the usefulness of Basophil activation test (BAT) to L-asparaginase hypersensitivity reaction |
| Date of disclosure of the study information | 2012/08/17 |
| Last modified on | 2012/08/17 20:05:51 |
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Basic information
Public title
Examination of the usefulness of Basophil activation test (BAT) to L-asparaginase hypersensitivity reaction
Acronym
L-asparaginase hypersensitivity reaction and BAT
Scientific Title
Examination of the usefulness of Basophil activation test (BAT) to L-asparaginase hypersensitivity reaction
Scientific Title:Acronym
L-asparaginase hypersensitivity reaction and BAT
Region
| Japan |
Condition
Condition
acute lymphoblastic leukemia
lymphoma
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine usefulness of Basophil activation test (BAT) to L-asparaginase hypersensitivity reaction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In having L-asparaginase hypersensitivity reaction or not,
Basophil activation test (BAT)
Drug-induced lymphocyte stimulation test (DLST)
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
| Not applicable |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient of acute lymphoblastic leukemia and lymphoma that received L-asparaginase, And a legal proxy agreed in St. Marianna University School of Medicine Hospital or collaboration institution.
Key exclusion criteria
There are not the exclusion criteria in particular.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitoshi Kinoshita |
Organization
St.marianna University school of Medicine Hospital
Division name
Department of pediatrics
Zip code
Address
2-16-1 Sugao, Miyamae-ku, kawasaki, kanagawa
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Keino |
Organization
St.marianna University school of Medicine Hospital
Division name
Department of pediatrics
Zip code
Address
2-16-1 Sugao, Miyamae-ku, kawasaki, kanagawa
TEL
044-977-8111
Homepage URL
d2keino@marianna-u.ac.jp
Sponsor or person
Institute
Department of pediatrics, St.marianna University school of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of pediatrics, Yokohama City University Hospital
Department of pediatrics, Showa University Fujigaoka Hospital
Kanagawa Children`s Medical Center
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
横浜市立大学付属病院 小児科(神奈川県)
昭和大学藤が丘病院 小児科(神奈川県)
神奈川県立こども医療センター 血液・再生医療科(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 17 | 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
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
In having L-asparaginase hypersensitivity reaction or not,
Basophil activation test (BAT)
Drug-induced lymphocyte stimulation test (DLST)
Management information
Registered date
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2012 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010237
