UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042515 |
|---|---|
| Receipt number | R000048531 |
| 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 |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2021/11/22 09:06:27 |
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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
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
k-yoko@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048531
