UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016808 |
|---|---|
| Receipt number | 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 09:52:57 |
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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
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
kt10948@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019507
