UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058338 |
|---|---|
| Receipt number | R000066692 |
| Scientific Title | HM-SCREEN-Japan02-First |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/13 16:13:47 |
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Basic information
Public title
Genomic screening study in patients with newly-diagnosed untreated acute myeloid leukemia
Acronym
Genome study for untreated AML
Scientific Title
HM-SCREEN-Japan02-First
Scientific Title:Acronym
HM02F
Region
| Japan |
Condition
Condition
Acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify patients with high-risk AML according to new criteria defined by genetic mutations and to determine the response factors (including genetic information) to standard chemotherapy, including Vyxeos(R), for these patients. In addition, we will verify whether the Amoy DX(R) Myeloid Blood Cancer Panel is of sufficient quality for clinical use in terms of time and accuracy of the test.
Basic objectives2
Others
Basic objectives -Others
Same above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The predictive ability of genomic information at the time of diagnosis for response will be the primary endpoint. To ensure the accuracy of the results, the information obtained from the previous HM-SCREE-Japan studies (HM01 and HM02) will also be integrated into the analysis.
Key secondary outcomes
1) Predictive ability of response as defined in the primary endpoint will be calculated separately for each regimen.
2) Evaluate the turn-around time (TAT) from specimen submission to report return.
3) The rate of concordance between the clinician-determined risk classification and the risk classification based on the ELN2020 classification will be evaluated.
4) Survival and progression-free survival will be evaluated for each risk category.
5) Collect clinical laboratory data (blood samples, bone marrow examination, cytogenetics, etc.) and treatment details (regimen, response determination, etc.) at the time of the screening, and analyze the association between genomic test results and clinical outcomes.
6) Questionnaires will be sent to researchers at each institution to qualitatively or semi-quantitatively evaluate the use of this kit (Amoy Myeloid Panel).
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
1)Pathologically or cytogenetically diagnosed acute myeloid leukemia.
2)In the case of acute transformation from MDS or MPN, the time when the patient first fulfills the diagnostic criteria for AML is considered the initial diagnosis, and treatment for MDS or MPN is not included in the history of prior treatment).
3) The patient must be eligible for standard chemotherapy and must be willing to receive treatment.
4) The patient must have reached the age of majority as defined by the Civil Code and must be able to give free and voluntary consent.
Key exclusion criteria
1) Patient is relapsed/refractory or has received prior therapy for AML at the time of enrollment.
2) No indication for or unwillingness to undergo standard chemotherapy
3) Inability to obtain an adequate specimen (bone marrow fluid or peripheral blood) containing myeloblasts
4) The patient has not reached the age of majority or is unable to give free and voluntary consent.
5) Other reasons why the physician in charge considers enrollment in this study inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Minami |
Organization
National Cancer Center East
Division name
Department of Hematology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa city, Chiba prefecture, Japan
TEL
04-7133-1111
yominami@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | SungGi |
| Middle name | |
| Last name | Chi |
Organization
National Cancer Center East
Division name
Department of Hematology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa city, Chiba prefecture, Japan
TEL
04-7133-1111
Homepage URL
schi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
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
National Cancer Center Ethics Review Board
Address
Kashiwanoha 6-5-1, Kashiwa city, Chiba prefecture, Japan
Tel
04-7133-1111
irst@ml.res.ncc.go.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 | 08 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
About Amoy Dx Myeloid Blood Cancer Panel (ver. 2)
The Amoy Dx Myeloid Blood Cancer Panel (abbreviated as Amoy Myeloid Panel) is a genome sequencing technology developed by Amoy using the HANDLE system (halo-shape The Amoy Dx Myeloid Blood Cancer Panel (abbreviated as Amoy Myeloid Panel) is a genome sequencing technology using the HANDLE system (halo-shape annealing and defer-ligation enrichment system) developed by Amoy [Blood, 2022. 140(Supplement 1): p. 10722-10724].
Genes to be analyzed
ABL1* CTCF IDH2 MYC RARA* TET2
ASXL1 DIS3 IKZF1 MYD88 RB1 TP53
BCOR DNMT3A JAK2* NF1 RIT1 U2AF1
BRAF ETV6* JAK3 NPM1* RUNX1* WT1
CALR EZH2 KIT NRAS SETBP1 ZRSR2
CBFB* FBXW7 KMT2A* NUP214* SF3B1
CBL FLT3 KRAS NUP98* SRSF2
CEBPA GATA1 MAX PDGFRA* STAG2
CREBBP* GATA2 MLLT10* PHF6 STIL*
CSF3R IDH1 MPL PTPN11 TCF3*
* includes fusion genes
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066692
