UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006733 |
|---|---|
| Receipt number | R000007954 |
| Scientific Title | Observational study of evaluation for chronic GVHD by using enumeration of cytokine-producing cells |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2011/11/15 20:43:05 |
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Basic information
Public title
Observational study of evaluation for chronic GVHD by using enumeration of cytokine-producing cells
Acronym
Cytokine-producing cells in chronic GVHD
Scientific Title
Observational study of evaluation for chronic GVHD by using enumeration of cytokine-producing cells
Scientific Title:Acronym
Cytokine-producing cells in chronic GVHD
Region
| Japan |
Condition
Condition
Patients after hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis and therapeutic evaluation for chronic GVHD
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathophysiology of chronic GVHD
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of cytokine-producing cells in active chronic GVHD
Key secondary outcomes
Role of monocyte in chronic GVHD
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
1.Provide signed, written informed consent.
2.at least 100 days after hematopoietic stem cell transplantation.
3.Patient without a serious complication except chronic GVHD at collection of blood sample.
4.Patient whom last observation day is made clear in a clinical record.
Key exclusion criteria
1.Patient that quantity of blood sampling is regarded as a physical burden for reasons of the age or the body weight.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirayama |
Organization
Mie University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-174 Edobashi, Tsu, Mie514-8507, Japan
TEL
059-232-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Hirayama |
Organization
Mie University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-174 Edobashi, Tsu, Mie514-8507, Japan
TEL
059-232-1111
Homepage URL
hirayama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 15 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The number of IL-10 producing cells in patients with active chronic GVHD was significantly higher than those with inactive or no chronic GVHD, and could be diagnostic and therapeutic marker. Moreover, IL-10 was predominantly produced by monocyte.
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2011 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007954
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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