UMIN-CTR Clinical Trial

Basic information
Public title	Study of investigating the mechanism of action of azacitidine in patients with myelodysplastic syndrome/acute myeloid leukemia with myelodysplasia-related changes by single cell RNA sequence
Acronym	scRNA-Aza
Scientific Title	Study of investigating the mechanism of action of azacitidine in patients with myelodysplastic syndrome/acute myeloid leukemia with myelodysplasia-related changes by single cell RNA sequence
Scientific Title:Acronym	scRNA-Aza
Region	Japan

Condition
Condition	myelodysplastic syndrome,acute myeloid leukemia with myelodysplasia-related changes
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To elucidate the serial change in single cell transcriptome profile before and after AZA therapy in patients with myelodysplastic syndrome and acute myeloid leukemia with myelodysplasia-related changes
Basic objectives2	Others
Basic objectives -Others	To elucidate the difference of single cell transcriptome profiel in azacytidine-responder versus -non-responder in myelodysplastic syndrome and acute myeloid leukemia with myelodysplasia-related changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the serial single cell transcriptome profile in responder versus non-responder
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with high-risk MDS and AML-MRC who underwent or who are undergoing AZA therapy
Key exclusion criteria	underage
Target sample size	30

Research contact person
Name of lead principal investigator	1st name KAZUAKI Middle name Last name YOKOYAMA
Organization	Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name	Department of Hematology/Oncology
Zip code	108-8639
Address	4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL	03-3443-8111
Email	k-yoko@ims.u-tokyo.ac.jp

Public contact
Name of contact person	1st name KAZUAKI Middle name Last name YOKOYAMA
Organization	Research Hospital, The Institute of Medical Science
Division name	Department of Hematology/Oncology
Zip code	108-8639
Address	4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL	03-3443-8111
Homepage URL
Email	k-yoko@ims.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	NIPPON SHINYAKU CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office of Reseach Ethics, The Institute of Medical Science, The University of Tokyo
Address	4-6-1 Shirokanedai, Minato-ku, Tokyo
Tel	03-3443-8111
Email	ken-rin@ims.u-tokyo.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	2020 Year 11 Month 24 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	17
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	2019 Year 11 Month 19 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2020 Year 03 Month 02 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not applicable

Management information
Registered date	2020 Year 11 Month 20 Day
Last modified on	2021 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048531