UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017443 |
|---|---|
| Receipt number | R000020158 |
| Scientific Title | Analysis of the growth mechanism of adult T-cell leukemia cells |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2016/01/20 14:32:15 |
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Basic information
Public title
Analysis of the growth mechanism of adult T-cell leukemia cells
Acronym
Growth mechanism of ATL
Scientific Title
Analysis of the growth mechanism of adult T-cell leukemia cells
Scientific Title:Acronym
Growth mechanism of ATL
Region
| Japan |
Condition
Condition
Adult T-cell leukemia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To study whether Gal-9 and HMGB1 have inhibitory effect in vitro on proliferation of peripheral lymphocytes obtained from ATL patients. In addition, lncRNA expression in PBMC from ATL patients will be analyzed.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Live cell counts (at day 1, 2,and 3 after incubation with Galectin-9 or HMGB1)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as ATL based on anti-HTLV1 antibody, blood feature, single clonal proliferation of HTLV-1 infected cells. Classify based on clinical features.
Key exclusion criteria
Patients who were less than 18 years old or does not have sufficient judgment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haorile Chagan-Yasutan |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8220
haorile@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haorile Chagan-Yasutan |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8220
Homepage URL
haorile@gmail.com
Sponsor or person
Institute
Disaster-related Infectious Disease, Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe City Hospital Organization
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
| 2015 | Year | 05 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One patient with chronic ATL was registered. Experiment using PBMC from this patient showed galectin-9 increased the percentage of apoptosis and necrotic cells.
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2016 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020158
