A study on the feasibility of the clinical sequence in acute myeloid leukemia

A study on the feasibility of the clinical sequence in acute myeloid leukemia - JALSG-CS-17-Molecular

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035041

Enrollment

1000

Registered

2018-12-01

Start date

2019-08-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML (acute myeloid leukemia)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Characterization of newly diagnosed AML which have low frequency gene mutation	—

Secondary

Measure	Time frame
(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.	—

Measure

Time frame

(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.

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Countries

Japan

Contacts

Public ContactHisayuki Yokoyama

Tohoku University Graduate School of Medicine Department of Hematology

hisayuki.yokoyama.a1@tohoku.ac.jp022-717-7165

Outcome results