UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030977 |
|---|---|
| Receipt number | R000029682 |
| Scientific Title | Prospective evaluation of minimal residual disease in acute myeloid leukemia using TIM-3 as a leukemia marker |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2019/07/29 12:21:20 |
* 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
Public title
Prospective evaluation of minimal residual disease in acute myeloid leukemia using TIM-3 as a leukemia marker
Acronym
MRD study for acute myeloid leukemia using TIM-3 as a leukemic stem cell specific surface marker
Scientific Title
Prospective evaluation of minimal residual disease in acute myeloid leukemia using TIM-3 as a leukemia marker
Scientific Title:Acronym
MRD study for acute myeloid leukemia using TIM-3 as a leukemic stem cell specific surface marker
Region
| Japan |
Condition
Condition
acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the correlation between the prognosis of acute myeloid leukemia and the TIM-3-expressing residual leukemic stem cells along with therapy progression
Basic objectives2
Others
Basic objectives -Others
Evaluation of usefulness of TIM-3 as a marker for residual AML cells
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between the prognosis of acute myeloid leukemia and the TIM-3-expressing residual leukemic stem cells
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Untreated acute myeloid leukemia(AML) patients
(2) The patients who understand the content of this study and agreed with participating in the study by own free will
(3) Age over 16 years
Key exclusion criteria
(1) Refractory or relapsed acute myeloid leukemia patients
(2)Secondary AML patients
(3)Acute promyelocytic leukemia patients
(4) A patient whom the researchers decide as an inappropriate case
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikane Kikushige |
Organization
Kyushu University
Division name
Department of Medicine and Biosystemic Sciences
Zip code
Address
3-1-1, Maidashi Higashiku, Fukuoka, Japan
TEL
092-642-5947
kikusige@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikane Kikushige |
Organization
Kyushu University
Division name
Department of Medicine and Biosystemic Sciences
Zip code
Address
3-1-1, Maidashi Higashiku, Fukuoka, Japan
TEL
092-642-5947
Homepage URL
kikusige@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Biosystemic Sciences, Kyushu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 24 | 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
| 2016 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sequential evaluation of TIM-3 positive AML cells using multi-color FACS
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029682
