UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017726 |
|---|---|
| Receipt number | R000020531 |
| Scientific Title | Resolution of Graves disease pathophysiology by flowcytometrey |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2017/12/19 12:40:53 |
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Basic information
Public title
Resolution of Graves disease pathophysiology by flowcytometrey
Acronym
Resolution of Graves disease pathophysiology
Scientific Title
Resolution of Graves disease pathophysiology by flowcytometrey
Scientific Title:Acronym
Resolution of Graves disease pathophysiology
Region
| Japan |
Condition
Condition
Graves disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is to clarify the pathogenesis of Graves' disease. We investigate the changes of cell surface markers, intracellular signal transducers and cell proliferation response of immunocompetent cells before and after the medication.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subset analysis of the abnormalities and changes after treatment of immunocompetent cells (T cell, B cell, dendritic cell, monocyte, macrophage, and natural killer cell) in Graves' disease.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have not received the treatment for Graves' disease
Age: 20 years of age and older. It does not matter gender.
Patients who agree with this study
Key exclusion criteria
Patients who refuse this study
Any patients whom the investigators judged to be inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Torimoto |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
Homepage URL
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
Prospective study
Subset analysis of the abnormalities and changes after treatment of immunocompetent cells (T cell, B cell, dendritic cell, monocyte, macrophage, and natural killer cell) in Graves' disease.
Management information
Registered date
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020531
