UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035041
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

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Basic information

Public title

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

Acronym

JALSG-CS-17-Molecular

Scientific Title

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

Scientific Title:Acronym

JALSG-CS-17-Molecular

Region

Japan


Condition

Condition

AML (acute myeloid leukemia)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -Others

To evaluate the feasibility of implementation for clinical sequencing AML

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Characterization of newly diagnosed AML which have low frequency gene mutation

Key secondary outcomes

(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.


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

80 years-old >

Gender

Male and Female

Key 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

Key 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

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Hisayuki
Middle name
Last name Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Hematology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan

TEL

022-717-7165

Email

hisayuki.yokoyama.a1@tohoku.ac.jp


Public contact

Name of contact person

1st name Hisayuki
Middle name
Last name Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Hematology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai-shi, 980-8574, Japan

TEL

022-717-7165

Homepage URL


Email

hisayuki.yokoyama.a1@tohoku.ac.jp


Sponsor or person

Institute

Japan Adult Leukemia Study Group(JALSG)

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2018 Year 12 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

602

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

2018 Year 11 Month 26 Day

Date of IRB

2018 Year 11 Month 15 Day

Anticipated trial start date

2018 Year 12 Month 22 Day

Last follow-up date

2027 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(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


Management information

Registered date

2018 Year 11 Month 28 Day

Last modified on

2023 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039439


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name