UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031343 |
|---|---|
| Receipt number | 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 | 2023/02/02 18:19:38 |
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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 | 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
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
+81227177165
Homepage URL
https://www.jalsg.jp/
hisayuki.yokoyama.a1@tohoku.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
Ethics Committee National Hospital Organization Sendai Medical Center
Address
2-8-8 Miyagino, Miyagino-ku, Sendai, Japan
Tel
022-293-1111
syokuin2132@snh.go.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 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
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
| 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=R000035780
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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