UMIN-CTR Clinical Trial

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
Last 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
Email	tanaka@med.uoeh-u.ac.jp

Public contact
1st 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
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	University of Occupational and Environmental Health
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
Tel	0936031611
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025709