UMIN-CTR Clinical Trial

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
Email	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
Email	officej2@jplsg.jp

Sponsor
Institute	JPLSG
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006027