Unique ID issued by UMIN | UMIN000035041 |
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Receipt number | R000039439 |
Scientific Title | A study on the feasibility of the clinical sequence in acute myeloid leukemia |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2023/02/02 18:11:20 |
A study on the feasibility of the clinical sequence in acute myeloid leukemia
JALSG-CS-17-Molecular
A study on the feasibility of the clinical sequence in acute myeloid leukemia
JALSG-CS-17-Molecular
Japan |
AML (acute myeloid leukemia)
Hematology and clinical oncology |
Malignancy
YES
To evaluate the feasibility of implementation for clinical sequencing newly diagnosed AML, and to characterize the background and prognosis of the population which have low frequency gene mutation.
Others
To evaluate the feasibility of implementation for clinical sequencing AML
Characterization of newly diagnosed AML which have low frequency gene mutation
(1) Percentage of gene mutation identified as PAF
(2) Average number of days required to return gene mutation analysis information to the attending doctor
(3) Percentage of analysis failure in genetic mutation
(4) Percentage of cases that received targeting therapy based on PAF reported from expert panel.
(5) Percentage of cases in which PAF reported from expert panel were used to determine the management of AML.
(6) Relationship between gene mutation and complete remission rates of initial treatment
(7) Relationship between gene mutation and survival rates
(8) Percentage of cases which needed genetic counseling
PAF is defined as a gene mutation that can provide information on WHO classification (WHO revised 4th edition), AML risk classification by ELN or NCCN, or gene mutations mentioned in genome guideline published by JSH.
Observational
16 | years-old | <= |
80 | years-old | > |
Male and Female
(1) Patients untreated AML, aged 16-79.
(2) Patients can be registered in the JALSG CS-17 study. *The definition of AML shall correspond to AML and related neoplasms in the WHO classification (WHO revised 4th edition)
(3) Performance status (ECOG) of 0-3 with sufficient liver, kidney, lung and heart function
(4) Those receiving standard anticancer drug treatment
(5) Provided written consent to participate in this study by themselves. Provided written consent by the representatives (custodians) for patients under the age of 20
(1) Those registered in an interventional study prescribing treatment by anti-cancer drugs
(2) Diagnosed with APL with PML-RARA, Myeloid sarcoma
(3) With active multiple cancers, poorly controlled diabetes, severe infections
1000
1st name | Hisayuki |
Middle name | |
Last name | Yokoyama |
Tohoku University Graduate School of Medicine
Department of Hematology
980-8574
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan
022-717-7165
hisayuki.yokoyama.a1@tohoku.ac.jp
1st name | Hisayuki |
Middle name | |
Last name | Yokoyama |
Tohoku University Graduate School of Medicine
Department of Hematology
980-8574
1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan
022-717-7165
hisayuki.yokoyama.a1@tohoku.ac.jp
Japan Adult Leukemia Study Group(JALSG)
Japan Agency for Medical Research and Development
Other
Japan
Ethics Committee Tohoku University Graduate School of Medicine
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
NO
2018 | Year | 12 | Month | 01 | Day |
Unpublished
602
No longer recruiting
2018 | Year | 11 | Month | 26 | Day |
2018 | Year | 11 | Month | 15 | Day |
2018 | Year | 12 | Month | 22 | Day |
2027 | Year | 08 | Month | 31 | Day |
(1)birth date, sex, diagnosis, percentage of blasts (BM, PB), requirement of disclosure of germline mutation
(2)selection of treatment in cases which obtain PAF
(3)using PAF as a reference for diagnosis or treatment
(4)requirement of genetic counseling
(5)prognosis
2018 | Year | 11 | Month | 28 | Day |
2023 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039439
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