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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035233
Receipt No. 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

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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
Email 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
Email kenmiyam@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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