UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017972 |
|---|---|
| Receipt number | R000020825 |
| Scientific Title | Biological marker predicts response to immunosuppressive therapy in pediatric aplastic anemia. |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2015/12/20 22:54:02 |
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Basic information
Public title
Biological marker predicts response to immunosuppressive therapy in pediatric aplastic anemia.
Acronym
Predicting the response IST in pediatric AA.
Scientific Title
Biological marker predicts response to immunosuppressive therapy in pediatric aplastic anemia.
Scientific Title:Acronym
Predicting the response IST in pediatric AA.
Region
| Japan |
Condition
Condition
Aplastic Anemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the biological marker for the predicting the response to IST in pediatric AA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between each biomarker and prognosis of IST.
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acqwired aplastic anemia
Less than 20 years old
Informed consent from patients and/or their parents
Key exclusion criteria
Congenital aplastic anemia, including Fanconii anemia, DKC etc.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Muramatsu |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2294
hideki-muramatsu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Narita |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2294
Homepage URL
anarita@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
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
| 2015 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Tha patients with shorter telomere length who had not minor PNH clone shows poor response to IST.
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
113 patients were analyzed.
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2015 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020825
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| Registered date | File name |
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