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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006733
Receipt No. 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

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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
Email

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
Email hirayama@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Pediatrics, Mie University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007954

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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