UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003432 |
|---|---|
| Receipt number | R000004156 |
| Scientific Title | Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia. -JALSG AML209 Genetic Study (AML209-GS)- |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2020/04/08 10:29:58 |
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Basic information
Public title
Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
-JALSG AML209 Genetic Study (AML209-GS)-
Acronym
Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
Scientific Title
Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
-JALSG AML209 Genetic Study (AML209-GS)-
Scientific Title:Acronym
Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia.
Region
| Japan |
Condition
Condition
Adult acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will comprehensively analyze the chromosomal and genetic alterations, which have been suggested to be involved in the development, progression and prognosis of acute myeloid leukemia. Based on these analyses, we intend to clarify the genotype which can stratify AML for adapting the individual therapy.
Basic objectives2
Others
Basic objectives -Others
Association of chromoaomal and genetic alterations with the prognosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease-free survival in each genotype.
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Untreated AML patients except for APL.
(2) The patients who will be received the chemotherapy for obtaining the cure of AML.
(3) The patients with Performance status grade (ECOG) 0,1,2 or 3.
(4) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions.
(5) The patients from whom the informed consent for the chemotherapy have been obtained.
Key exclusion criteria
1. The patients who had received chemotherapy, irradiation or hematopoietic stem cell transplantation against acute leukemias of ambiguous lineage, myeloproliferative neoplasms, myeloid and lymphoid neoplasms with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1.
2. The patients with natural killer cell lymphoblastic leukemia / lymphoma.
3. The patients with active cancer.
4. The patients who developed myocardial infarction within 1 year.
5. The patients with diabetes which is uncontrollable even with insulin.
6. The patients with active infection.
7. The patients with liver cirrhosis.
8. The patients who have the past history of renal dysfunction.
9. The patients with deep vein thrombosis requiring the treatment.
10. The patients with psychological disease.
11. The women who is or may be in pregnancy.
12. The HBV antigen or HIV antibody positive patients.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kiyoi |
| Middle name | |
| Last name | Hitoshi |
Organization
Nagoya University Hospital
Division name
Department of Hematology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2136
kiyoi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoi |
| Middle name | |
| Last name | Hitoshi |
Organization
Nagoya University Hospital
Division name
Department of Hematology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2136
Homepage URL
http://www.jalsg.jp/
kiyoi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japan adult leukemia study group
Institute
Department
Personal name
Funding Source
Organization
NPO JALSG
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committe of Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-744-2804
ethics@med.nagoya-u.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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
1826
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Analyzing genotype)
1. Karyotype
2. FLT3 gene mutation
3. NPM1 gene mutation
4. CEBPA gene mutation
5. MLL-PTD mutation
6. KIT gene mutation
7. NRAS gene mutation
8. TP53 gene mutation
9. WT1 gene mutation
10. IDH1 gene mutation
11. Combination of above genotypes
(Assessment issues)
1. Disease-free survival at 5 year in each genotype.
2. Overall survival at 5 year in each genotype.
3. Association of hematopoietic stem cell transplantation with DFS and OS in each genotype.
4. Complete remission rate in each genotype.
5. Proportion of each genotype in adult AML.
6. Association of each genotype with previously established prognostic factors.
7. Association of each genotype with the FAB classification and WHO classification.
8. Association of each genotype with the clinical characteristics at the diagnosis.
Management information
Registered date
| 2010 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004156
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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