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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031343
Receipt No. R000035780
Scientific Title Observational Study of viability of the clinical sequencing for AML (JALSG CS-17-CSeq)
Date of disclosure of the study information 2018/02/19
Last modified on 2019/02/17

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Basic information
Public title Observational Study of viability of the clinical sequencing for AML (JALSG CS-17-CSeq)
Acronym Observational Study of viability of the clinical sequencing for AML (JALSG CS-17-CSeq)
Scientific Title Observational Study of viability of the clinical sequencing for AML (JALSG CS-17-CSeq)
Scientific Title:Acronym Observational Study of viability of the clinical sequencing for AML (JALSG CS-17-CSeq)
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 assess the viability of the clinical sequencing for AML(acute myeloid leukemia) and calculate the rate of the patients with potentially actionable findings by the targeted sequencing analysis.
Basic objectives2 Others
Basic objectives -Others To assess the viability of the clinical sequencing for AML
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification rate of patients with potentially actionable findings(PAF) by introduction of the clinical sequencing.
Key secondary outcomes Identification rate of the clinically impactful findings (CIF).
The average number of days required to return the genome analysis information to the doctor in charge.
Identification rate of patients in which the genome cannot be analyzed and its causes.
Identification rate of patients that germ cell sequence mutations were identified which are supposed to return the information report.

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) Age 16-79y at the time of initial diagnosis.
(2) Untreated AML. AML are defined in accordance with the Acute myeloid leukemia (AML) and related neoplasms in WHO classification, 2016 edition.
(3) ECOG performance status score:0-3 and sufficient hepatic, renal, and cardiac function satisfying the laboratory data.
(4) Patients who have the standard anticancer drug treatments.
(5) Patients who provided written informed consent for this study by themselves.
(6) Patients who are under 20 years of age are required to give informed consent by legally acceptable representative.
Key exclusion criteria (1)APL with PML-RARA, Myeloid sarcoma
(2) Less than 30% of blast and meet the RAEB-t in the FAB classification.
(3)Patients with complications including an activity double cancer, uncontrolled diabetes, and a serious infection.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisayuki Yokoyama
Organization National Hospital Organization Sendai Medical Center
Division name Department of Hematology
Zip code
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
1st name
Middle name
Last name Hisayuki Yokoyama
Organization National Hospital Organization Sendai Medical Center
Division name Department of Hematology
Zip code
Address 2-8-8 Miyagino, Miyagino-ku, Sendai-shi, 983-8520, Japan
TEL 022-293-1111
Homepage URL https://www.jalsg.jp/
Email yokoyamah@snh.go.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 19 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
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 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is additional study of "JALSG AML/MDS/CMML Clinical Observational Study (JALSG-CS)-17", and UMIN ID is UMIN000027961.

Management information
Registered date
2018 Year 02 Month 16 Day
Last modified on
2019 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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