UMIN-CTR Clinical Trial

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
Email	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
Email	torimoto@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020531

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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