UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054812 |
|---|---|
| Receipt number | R000062633 |
| Scientific Title | A multicenter collaborative study of genetic analysis using the Amoy Myeloid Panel, a specific gene genome sequencing kit, for patients with chronic myeloid leukemia in the chronic phase who are resistant or intolerant to existing tyrosine kinase inhibitors. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/06/06 13:26:07 |
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Basic information
Public title
A multicenter collaborative study of genetic analysis using the Amoy Myeloid Panel, a specific gene genome sequencing kit, for patients with chronic myeloid leukemia in the chronic phase who are resistant or intolerant to existing tyrosine kinase inhibitors.
Acronym
Hematologic Malignancies (HM)-SCREEN-Japan CML
Scientific Title
A multicenter collaborative study of genetic analysis using the Amoy Myeloid Panel, a specific gene genome sequencing kit, for patients with chronic myeloid leukemia in the chronic phase who are resistant or intolerant to existing tyrosine kinase inhibitors.
Scientific Title:Acronym
HM-SCREEN-Japan CML
Region
| Japan |
Condition
Condition
Chronic myeloid leukemia chronic phase
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In patients with chronic myeloid leukemia in the chronic phase who are resistant or intolerant to existing tyrosine kinase inhibitors and are considering the introduction of the STAMP inhibitor asciminib, we will analyze the relationship between the presence or absence of somatic mutations before the asciminib treatment and the clinical course by analyzing gene mutations using a specific gene sequence kit (Amoy Myeloid Panel).
Basic objectives2
Others
Basic objectives -Others
Feasibility of the sequencing kit in optimizing the diagnosis of CML
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance of the clinical course and the genomic information.
Key secondary outcomes
Assessment of the relationship between adverse events of treatment and gene mutation information
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 with chronic myeloid leukemia.
2) Chronic phase at the time of enrollment.
3) Resistant or intolerant to two or more TKIs, and must be considering administering asciminib (regardless of whether or not they have subsequently been administered TKIs).
4) The age of majority as defined by the Civil Code and be able to give his/her consent.
Key exclusion criteria
1) Attending physician judges to be inappropriate for enrollment in this study
2) History of asciminib administration
Target sample size
50
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
6-5-1 Kashiwanoha, Kashiwa City, Chiba
TEL
04-7133-1111
yominami@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Katagiri |
Organization
Tokyo Medical University Hospital
Division name
Department of Hematology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
katagiri@tokyo-med.ac.jp
Sponsor or person
Institute
National Cancer Center East
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
National Cancer Center East
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Amoy Diagnostics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Tyuuouku, Tokyo City
Tel
03-3542-2511
NCC_IRBoffice@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
愛知県がんセンター (愛知県), 秋田大学医学部附属病院 (秋田県), NTT東日本関東病院 (東京都), 大阪大学医学部附属病院 (大阪府), 京都府立医科大学附属病院 (京都府), 国立がん研究センター中央病院 (東京都), 日本赤十字社愛知医療センター 名古屋第一病院 (愛知県), 福井大学医学部附属病院 (福井県), 成田赤十字病院 (千葉県), 浜松医科大学医学部附属病院 (静岡県), 札幌医科大学附属病院 (北海道), 愛育病院 (北海道), 高知大学医学部附属病院 (高知県), 山口大学医学部付属病院 (山口県), 鹿児島大学病院 (鹿児島県), 千葉大学医学部附属病院 (千葉県), 福島県立医科大学附属病院 (福島県), 水戸医療センター (茨城県), 佐賀県医療センター好生館 (佐賀県), 京都大学医学部附属病院 (京都府), 亀田総合病院 (千葉県), 愛媛県立中央病院 (愛媛県), 獨協医科大学埼玉医療センター (栃木県), 東北大学病院 (福島県), 東京医科歯科大学 (東京都), 岩手医科大学附属病院 (岩手県), 岩手県立中央病院 (岩手県), 東京大学医科学研究所附属病院 (東京都), 埼玉医科大学総合医療センター (埼玉県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062633
