UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048611 |
|---|---|
| Receipt number | R000055333 |
| Scientific Title | Analysis of gene mutations and clinical response and mechanisms of leukemogenesis in acute leukemia |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2024/02/06 10:46:12 |
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Basic information
Public title
Analysis of gene mutations and clinical response and mechanisms of leukemogenesis in acute leukemia
Acronym
Hokkaido Leukemia Net
Scientific Title
Analysis of gene mutations and clinical response and mechanisms of leukemogenesis in acute leukemia
Scientific Title:Acronym
Hokkaido Leukemia Net
Region
| Japan |
Condition
Condition
acute leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Relationship of genomic alteration and prognosis of acute leukemia is analyzed in Japanese prospective real-world cohort study.
Basic objectives2
Others
Basic objectives -Others
Evaluation of efficacy of international or domestic prognostic classification
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Relapse free 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) a patient clinically suspected acute leukemia
2) age equal or more than 16
3) a patient who agree to preserve specimen
4) a patient who agree to register this trial
Key exclusion criteria
1) a patient whose leukemic genome DNA or cDNA is not available
2) a patient who is considered as inappropriate to register this trial
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Onozawa |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
+81-11-706-7214
onozawa@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Onozawa |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
+81-11-706-7214
Homepage URL
onozawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Department of Hematology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
+81-11-706-7061
crjimu@huhp.hokudai.ac.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
北海道大学病院（北海道）
旭川医科大学（北海道）
札幌医科大学附属病院（北海道）
岩手医科大学附属病院（岩手県）
札幌北楡病院（北海道）
愛育病院（北海道）
市立札幌病院（北海道）
北海道勤労者医療協会勤医協中央病院（北海道）
JA北海道厚生連札幌厚生病院（北海道）
手稲渓仁会病院（北海道）
天使病院（北海道）
KKR札幌医療センター斗南病院（北海道）
国立病院機構北海道がんセンター（北海道）
市立旭川病院（北海道）
JA北海道厚生連帯広厚生病院（北海道）
独立行政法人労働者健康安全機構釧路ろうさい病院（北海道）
北見赤十字病院（北海道）
市立函館病院（北海道）
旭川厚生病院（北海道）
市立根室病院（北海道）
製鉄記念室蘭病院（北海道）
札幌徳洲会病院（北海道）
福島県立医科大学附属病院(福島県)
福島県立医科大学会津医療センター(福島県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36572814/
Number of participants that the trial has enrolled
Results
Clinical features of complex karyotype in newly diagnosed acute myeloid leukemia
Results date posted
| 2023 | Year | 02 | Month | 05 | Day |
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Genetic analysis
AML: FLT3, NPM1, CEBPA, KIT mutation, others
ALL: IKZF1 deletion, others
Management information
Registered date
| 2022 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055333
| 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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