UMIN-CTR Clinical Trial

Basic information
Public title	The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Acronym	The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Scientific Title	The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Scientific Title:Acronym	The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Region	Japan

Condition
Condition	Graves' disease, Hashimoto's thyroiditis, Thyroid nodules, subacute thyroiditis
Classification by specialty	Medicine in general Endocrinology and Metabolism Ophthalmology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	thyroid function test
Key secondary outcomes	anti-thyroid antibodies, TRAb, TSAb, ultrasonography

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
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Interventions/Control_10

Eligibility
Age-lower limit	13 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with thyroid disease who had visited Wakayama Medical University.
Key exclusion criteria	Patients who were pregnant or who had cancer, inflammatory disease, or thyroid nodules larger than 10 mm in diameter were excluded
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Akamizu
Organization	Wakayama Medical University
Division name	The 1st Department of Internal Medicine
Zip code
Address	811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL	073-441-0625
Email	akamizu@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Takeshima
Organization	Wakayama Medical University
Division name	The 1st Department of Internal Medicine
Zip code
Address	811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL	073-447-2300
Homepage URL
Email	kt10948@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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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 03 Month 16 Day

Related information
URL releasing protocol	http://www.ncbi.nlm.nih.gov/pubmed/24256421
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/24256421
Number of participants that the trial has enrolled
Results	The association with IgG4-related disease was implied in some cases with Graves' disease, Hashimoto's thyroiditis and Riedel thyroiditis.
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	2012 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 16 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information	Distribution of serum IgG4 levels in patients with thyroid disease.

Management information
Registered date	2015 Year 03 Month 16 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019507

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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