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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046371
Receipt No. R000052887
Scientific Title A Feasibility Study of Amoy Myeloid Panel (R) (a targeted genomic sequencing kit) in Optimizing Diagnosis of Acute Myeloid Leukemia: Hematologic Malignancies (HM)-SCREEN-Japan 02
Date of disclosure of the study information 2022/01/17
Last modified on 2021/12/14

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Basic information
Public title Genomic Sequencing Study for Acute Myeloid Leukemia
Acronym Genomic Sequencing Study for Acute Myeloid Leukemia
Scientific Title A Feasibility Study of Amoy Myeloid Panel (R) (a targeted genomic sequencing kit) in Optimizing Diagnosis of Acute Myeloid Leukemia: Hematologic Malignancies (HM)-SCREEN-Japan 02
Scientific Title:Acronym HM02
Region
Japan

Condition
Condition Acute myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Assessing the feasibility of the Amoy Myeloid Panel in terms of optimizing the diagnosis of AML.
Basic objectives2 Others
Basic objectives -Others Feasibility of the sequencing kit in optimizing the diagnosis of AML
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Concordance of the clinical diagnosis and the genomic information.
Key secondary outcomes Frequency and distribution of genomic abnormalities.
Overall survival

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. Histologically or cytologically diagnosed with AML
2. Adult patient who are able to give his/her consent.
Key exclusion criteria 1. Clinically inappropriate to join this study.
2. Absent leukemic cells in both the bone marrow and the peripheral blood.
Target sample size 200

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
TEL 04-7133-1111
Email 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 6-5-1 Kashiwanoha, Kashiwa City
TEL 04-7133-1111
Homepage URL
Email schi@east.ncc.go.jp

Sponsor
Institute National Cancer Center East
Department of Hematology
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Amoy Diagnostics
Name of secondary funder(s) CMIC

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji, Tyuuouku, Tokyo City
Tel 03-3542-2511
Email 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 国立がん研究センター東病院(千葉県)、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(静岡県)、札幌医科大学附属病院(北海道)、愛育病院(東京都)、東京医科大学(東京都)、高知大学(高知県)、山口大学医学部付属病院(山口県)、鹿児島大学(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(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)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 17 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
2021 Year 11 Month 19 Day
Date of IRB
2021 Year 12 Month 01 Day
Anticipated trial start date
2022 Year 01 Month 17 Day
Last follow-up date
2024 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
2021 Year 12 Month 14 Day
Last modified on
2021 Year 12 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052887

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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