UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009674 |
|---|---|
| Receipt number | R000011348 |
| Scientific Title | Prediction of acute GVHD following hematopoietic stem cell transplantation by using MLR-ELISPOT assay |
| Date of disclosure of the study information | 2012/12/31 |
| Last modified on | 2023/01/27 12:47:25 |
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Basic information
Public title
Prediction of acute GVHD following hematopoietic stem cell transplantation by using MLR-ELISPOT assay
Acronym
Prediction of acute GVHD by MLR- ELISPOT assay
Scientific Title
Prediction of acute GVHD following hematopoietic stem cell transplantation by using MLR-ELISPOT assay
Scientific Title:Acronym
Prediction of acute GVHD by MLR- ELISPOT assay
Region
| Japan |
Condition
Condition
Hematological disease for hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prediction of acute GVHD before hematopoietic stem cell transplantation
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathophysiology of acute GVHD
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between donor IFN-gamma production ability to recipient and acute GVHD
Key secondary outcomes
Correlation between donor IL-10 production ability to recipient and acute 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. Possible obtaining peripheral blood from donor and recipient before hematopoietic stem cell transplantation. 3. Patient without a serious complication except acute GVHD at collection of blood sample.
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
25
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hirayama |
Organization
Mie University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
+81-059-232-1111
hirayama@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hirayama |
Organization
Mie University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
+81-059-232-1111
Homepage URL
hirayama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Masahiro Hirayama
Funding Source
Organization
Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie Universisty
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
+81-59-231-5045
s-kenkyu@mo.medic.mie-u.ac.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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
We expect that donor IFN-gamma producing ability to recipient is connected with activity of acute GVHD before hematopoietic stem cell transplantation.
Management information
Registered date
| 2012 | Year | 12 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011348
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
