UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054913 |
|---|---|
| Receipt number | R000062737 |
| Scientific Title | Establishment of a Multiparameter Flow Cytometry (MFC) Method for Measuring Minimal Residual Disease in Acute Myeloid Leukemia |
| Date of disclosure of the study information | 2024/07/09 |
| Last modified on | 2024/07/09 12:15:45 |
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Basic information
Public title
Establishment of a Multiparameter Flow Cytometry (MFC) Method for Measuring Minimal Residual Disease in Acute Myeloid Leukemia
Acronym
Establishment of MFC Method for Measuring MRD in AML
Scientific Title
Establishment of a Multiparameter Flow Cytometry (MFC) Method for Measuring Minimal Residual Disease in Acute Myeloid Leukemia
Scientific Title:Acronym
Establishment of MFC Method for Measuring MRD in AML
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Correlation between MRD Trends before, during, and after Treatment and Prognosis in AML
Basic objectives2
Others
Basic objectives -Others
Comparison of the effectiveness and diagnostic accuracy between the MRD detection method in this study and existing methods
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between MRD Trends before, during, and after Treatment and Prognosis in AML
Key secondary outcomes
Correlation between Existing Methods for MRD Detection (such as the LAIP Method in Flow Cytometry, Chimeric Gene PCR, WT1, etc.) and the Flow Cytometry Method Examined in this Study, and Comparison of the Sensitivity of Each Method
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 and older diagnosed with AML who, as of the date of approval for this study, participated in the 'Kyushu Clinical Sample Network (KCNET)' study and who have also consented to the secondary use of their data.
Key exclusion criteria
(1) If the principal investigator, research director, or attending physician determines that enrollment in the study is inappropriate.
(2) If the collection of samples is deemed unsafe for the patient or donor.
(3) If, for any reason, it is difficult to collect samples.
(4) If a lack of research funding makes it difficult to maintain the 'Kyushu Clinical Sample Network (KCNET)' study.
Target sample size
240
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, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5947
kikushige.yoshikane.726@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Sakoda |
Organization
Kyushu University Hospital
Division name
Hematology, Oncology, and Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5947
Homepage URL
sakoda.teppei.476@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
Institutional Review Boards / Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
092-642-5082
ijkseimei@jimu.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
九州大学病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 09 | 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
240
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
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[References]
1. Heuser, M., et al., 2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party. Blood, 2021. 138(26): p. 2753-2767.
2. Rohnert, M.A., et al., Reproducible measurable residual disease detection by multiparametric flow cytometry in acute myeloid leukemia. Leukemia, 2022. 36(9): p. 2208-2217.
3. Kikushige, Y., et al., TIM-3 is a promising target to selectively kill acute myeloid leukemia stem cells. Cell Stem Cell, 2010. 7(6): p. 708-17.
Management information
Registered date
| 2024 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062737
