UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031734 |
|---|---|
| Receipt number | R000036060 |
| Scientific Title | Japanese Pediatric Leukemia/Lymphoma Study Group Prospective observational study of relapsed/refractory pediatric acute myeloid leukemia |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2023/03/18 16:22:21 |
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Basic information
Public title
Japanese Pediatric Leukemia/Lymphoma Study Group
Prospective observational study of relapsed/refractory pediatric acute myeloid leukemia
Acronym
JPLSG-AML-R15
Scientific Title
Japanese Pediatric Leukemia/Lymphoma Study Group
Prospective observational study of relapsed/refractory pediatric acute myeloid leukemia
Scientific Title:Acronym
JPLSG-AML-R15
Region
| Japan |
Condition
Condition
Relapsed/refractory acute myeloid leukemia
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify novel prognostic factors
Basic objectives2
Others
Basic objectives -Others
To investigate cytogenetic pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year overall, event-free, and progression-free survival after diagnosis of relapsed/refractory acute myeloid leukemia
3-year overall, event-free, and progression-free survival after hematopoietic stem cell transplantation
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
| 1 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children aged <18 years diagnosed with acute myeloid leukemia and relapsed aged <25 years
Children aged <18 years diagnosed with primary induction failure
Key exclusion criteria
Additional or multiple relapsed patients
Patients with secondary acute myeloid leukemia
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Moritake |
Organization
University of Miyazaki
Division name
Division of Pediatrics
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL
0985850989
hiroshi_moritake@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | HIroshi |
| Middle name | |
| Last name | Moritake |
Organization
University of Miyazaki
Division name
Division of Pediatrics
Zip code
8891692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL
0985-85-0989
Homepage URL
hiroshi_moritake@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of MIyazaki
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
Tel
0985850989
hiroshi_moritake@med.miyazaki-u.ac.jp
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
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036060
| 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 |
