UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035041
Receipt No. R000039439
Official scientific title of the study 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 2018/11/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study A study on the feasibility of the clinical sequence in acute myeloid leukemia
Title of the study (Brief title) 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 Hisayuki Yokoyama
Organization National Hospital Organization Sendai Medical Center
Division name Department of Hematology
Address 2-8-8 Miyagino, Miyagino-ku, Sendai-shi, 983-8520, Japan
TEL 022-293-1111
Email yokoyamah@snh.go.jp

Public contact
Name of contact person Hisayuki Yokoyama
Organization National Hospital Organization Sendai Medical Center
Division name Department of Hematology
Address 2-8-8 Miyagino, Miyagino-ku, Sendai-shi, 983-8520, Japan
TEL 022-293-1111
Homepage URL
Email yokoyamah@snh.go.jp

Sponsor
Institute Japan Adult Leukemia Study Group(JALSG)
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Anticipated trial start date
2018 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.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


Contact us.