UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035233 |
|---|---|
| Receipt number | R000040150 |
| Scientific Title | An Actionable Mutation Profiling Multicenter study of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for the First Standard Treatment or relapse/refractory Acute Myeloid Leukemia |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2018/12/13 12:21:30 |
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Basic information
Public title
An Actionable Mutation Profiling Multicenter study of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for the First Standard Treatment or relapse/refractory Acute Myeloid Leukemia
Acronym
HM-SCREEN-Japan01
Scientific Title
An Actionable Mutation Profiling Multicenter study of Patients with Newly Diagnosed Acute Myeloid Leukemia Unfit for the First Standard Treatment or relapse/refractory Acute Myeloid Leukemia
Scientific Title:Acronym
HM-SCREEN-Japan01
Region
| Japan |
Condition
Condition
acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency or characteristics of cancer genome alterations in acute myeloid leukemia.
Basic objectives2
Others
Basic objectives -Others
Feasibility Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency or characteristics of cancer genome alteration
Key secondary outcomes
Association between each cancer genome alterations and clinicopathological characteristics or prognosis, Quality of the specimen contributing to gene analysis
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
1) Pathologically proven acute myeloid leukemia.
2) Any of the following requirements is satisfied. i) Patient with newly diagnosed acute myeloid leukemia unfit for the first standard treatment
ii) Patient with relapse or refractory acute myeloid leukemia.
3) Sufficient sample is collected by bone marrow aspiration
4) Age at registration is of 20 years or older.
5) Witten informed consent is taken.
Key exclusion criteria
1) Patient is judged by the investigator to be inappropriate for study participation for any reason.
2) Pathologically proven granulocytic sarcoma.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Minami |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba, Japan, 277-8577
TEL
0471331111
yominami@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Miyamoto |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba, Japan, 277-8577
TEL
0471331111
Homepage URL
kenmiyam@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 12 | Month | 13 | 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
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040150
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
