UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on thyroid eye diseases
Acronym	Thyroid eye diseases
Scientific Title	Observational study on thyroid eye diseases
Scientific Title:Acronym	Thyroid eye diseases
Region	Japan

Condition
Condition	Graves' diasease
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between thyroid eye diseases and thyroid associated parameters.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eye functions
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with thyroid disease
Key exclusion criteria	Patients without thyroid disease
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Takeshima
Organization	Wakayama Medical University
Division name	First Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimi-idera, Wakayama
TEL	0734410625
Email	kt10948@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Takeshima
Organization	Wakayama Medical University
Division name	First Department of Internal Medicine
Zip code	641-8509
Address	811-1 Kimi-idera, Wakayama
TEL	0734410625
Homepage URL
Email	kt10948@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
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	the Wakayama Medical University Hospital Ethics Committee
Address	811-1 Kimi-idera, Wakayama
Tel	073-441-0887
Email	wa-rinri@wakayama-med.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	2021 Year 02 Month 02 Day

Related information
URL releasing protocol	Nothing
Publication of results	Unpublished

Result
URL related to results and publications	Nothing
Number of participants that the trial has enrolled	122
Results	Tear secretion is associated with tear quality in patients with Graves disease.
Results date posted	2022 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Graves disease
Participant flow	Patients with Graves' disease are entried into the study.
Adverse events	Nothing
Outcome measures	Thyroid function, TRAb, TSAb, clinical activity score, NOSPECS criteria, Ocular protrusion test, Schirmer test, Break up time, Meiboscore
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 08 Day
Date of IRB	2018 Year 05 Month 08 Day
Anticipated trial start date	2018 Year 05 Month 08 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cases are accumulated appropriately.

Management information
Registered date	2021 Year 02 Month 01 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049323