UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022316 |
|---|---|
| Receipt number | R000025709 |
| Scientific Title | The research for pathology and organ dysfunction of thyroid disease: a retrospective study |
| Date of disclosure of the study information | 2016/05/15 |
| Last modified on | 2019/05/18 17:55:16 |
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Basic information
Public title
The research for pathology and organ dysfunction of thyroid disease: a retrospective study
Acronym
The research for pathology and organ dysfunction of thyroid disease
Scientific Title
The research for pathology and organ dysfunction of thyroid disease: a retrospective study
Scientific Title:Acronym
The research for pathology and organ dysfunction of thyroid disease
Region
| Japan |
Condition
Condition
Thyroid disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pathology and oran dysfunction for thyroid disease including Basedow disease are not yet clarified. Patients with Basedow disease present with elevated IgG4 levels, and Basedow disease type IgG4 thyroiditis has been reported as a subtype of Basedow disease. However, many questions concerning the pathology of Basedow disease type IgG4 thyroiditis remain to be addressed, and its clinical features have not yet been established.
The aim of the present study was to determine the differences in clinical features and organ dysfunction of patients with Basedow disease and IgG4 thyroiditis.
Basic objectives2
Others
Basic objectives -Others
elucidate the pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of the was to determine the differences in clinical features of patients with Basedow disease and other thyroid 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Thyroid disease and other endocrine disease who were managed at our hospital.
Key exclusion criteria
1)patients with severe renal dysfunction including haemodialysis
2)patients with thyroid storm or myxedema coma
3)patients with pregnant or possibly pregnant women
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
807-8555
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 | Keiichi |
| Middle name | |
| Last name | Torimoto |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine, School of Medicine
Zip code
807-8555
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
University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
Tel
0936031611
sunday@pub.uoeh-u.ac.jp
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
| 2016 | Year | 05 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The pathology and oran dysfunction for thyroid disease including Basedow disease are not yet clarified. Patients with Basedow disease present with elevated IgG4 levels, and Basedow disease type IgG4 thyroiditis has been reported as a subtype of Basedow disease. However, many questions concerning the pathology of Basedow disease type IgG4 thyroiditis remain to be addressed, and its clinical features have not yet been established.
The aim of the present study was to determine the differences in clinical features and organ dysfunction of patients with Basedow disease and IgG4 thyroiditis.
Management information
Registered date
| 2016 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025709
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
