UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058313 |
|---|---|
| Receipt number | R000066667 |
| Scientific Title | Evaluating the efficacy of 10-color muli-parameter FCM-based MRD methods in acute myeloid leukemia |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/06/30 12:23:00 |
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Basic information
Public title
Evaluating the efficacy of 10-color muli-parameter FCM-based MRD methods in acute myeloid leukemia
Acronym
10-color FCM-MRD in AML
Scientific Title
Evaluating the efficacy of 10-color muli-parameter FCM-based MRD methods in acute myeloid leukemia
Scientific Title:Acronym
EV10CMRD study
Region
| Japan |
Condition
Condition
acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Establishment of 10-color multi-parameter FCM-based MRD assay in AML
Basic objectives2
Others
Basic objectives -Others
Comparison of WT1-mRNA levels vs. 10-color MFC-MRD levels in AML
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of WT1-mRNA levels vs. 10-color MFC-MRD levels at the time of pre-relapse phases including 3 and 6 months before clinical release of AML(retrospective comparison)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AML patients whose samples were preserved based on KCNET protocol in Kyushu University Hospital
Key exclusion criteria
Key exclusion criteria are defined by the preceding KCNET protocol
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshikane |
| Middle name | |
| Last name | Kikushige |
Organization
Kyushu University Hospital
Division name
Center for Cellular and Molecular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka, Japan
TEL
092-642-5947
kikusige@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikane |
| Middle name | |
| Last name | Kikushige |
Organization
Kyushu University Hospital
Division name
Center for Cellular and Molecular medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka, Japan
TEL
092-642-5947
Homepage URL
kikusige@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Yoshikane Kikushige
Funding Source
Organization
Astellas pharma inc
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
Kyushu University
Address
3-1-1, Maidashi, Higashiku, Fukuoka, Japan
Tel
092-642-5315
yoshikawa.miyuki.312@m.kyushu-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
| 2025 | Year | 07 | Month | 07 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study for evaluating the efficacy of multi-parameter FCM methods to detect the measurable residual disease(MRD) in acute myeloid leukemia.
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066667
