UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005418 |
|---|---|
| Receipt number | R000006027 |
| Scientific Title | Multicenter retrospective study for trasient abnormal myelopoiesis (JPLSG TAM-10) |
| Date of disclosure of the study information | 2011/04/15 |
| Last modified on | 2021/04/16 11:48:08 |
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Basic information
Public title
Multicenter retrospective study for trasient abnormal myelopoiesis (JPLSG TAM-10)
Acronym
JPLSG TAM-10
Scientific Title
Multicenter retrospective study for trasient abnormal myelopoiesis (JPLSG TAM-10)
Scientific Title:Acronym
JPLSG TAM-10
Region
| Japan |
Condition
Condition
Transient abnormal myelopoiesis
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to clarify the short term and long term prognosis of patients with transient abnormal myelopoiesis by multicenter prospective observational study.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event free survival
Key secondary outcomes
Overall survival
Proportion of patients who received chemotherapy
Percentage of adverse events
Cumulative incidence of progression to acute leukemia
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 | months-old | <= |
Age-upper limit
| 3 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria is as follows:
1) Patient is diagnosised as Down syndrome or mosaic Down syndrome. But patients without Down syndrome who has megakaryocytic blast with GATA1 mutation and somatic trisomy 21 are including to this study.
2) Patient is diagnosed with transient abnormal myelopoiesis under 90 das after birth.
3) Registration should be done within 30 days after diagnosis.
4) Diagnosed day should be after the opening day of this study.
5) Written informed concent by patient's guardian should be obtained.
Key exclusion criteria
none
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kikuchi |
Organization
Teikyo University School of Medicine
Division name
Department of Pediatrics
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
hideki-muramatsu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Nishioka |
Organization
JPLSG
Division name
TAM committee
Zip code
460-0001
Address
3-1-1, San-nomaru, Naka-ku, Nagoya, Japan
TEL
052-228-7159
Homepage URL
http://www.jplsg.jp/10siken_sankasisetu/fre_shiken_sannkasisetu.htm
officej2@jplsg.jp
Sponsor or person
Institute
JPLSG
Institute
Department
Personal name
Funding Source
Organization
Transient abnormal myelopoiesis with Down syndrome research group
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
Nagoya University Hospital
Address
65, Tsurumai-cho, showa-ku, Nagoya
Tel
0527412111
hideki-muramatsu@med.nagoya-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
| 2011 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41375-021-01171-y
Number of participants that the trial has enrolled
167
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
Main results already published
Date of protocol fixation
| 2011 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyzed the short term and long term outcome of patients with transient abnormal myelopoiesis.
Management information
Registered date
| 2011 | Year | 04 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006027
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
