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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016808
Receipt No. R000019507
Scientific Title The significance of serum immunoglobulin G4 and cytokine levels in patients with thyroid disease.
Date of disclosure of the study information 2015/03/16
Last modified on 2016/04/02

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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
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
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)
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 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&#39; disease, Hashimoto&#39;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
Registered date File name

Research case data
Registered date File name

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