UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043217 |
|---|---|
| Receipt number | R000049323 |
| Scientific Title | Observational study on thyroid eye diseases |
| Date of disclosure of the study information | 2021/02/02 |
| Last modified on | 2022/08/04 17:09:16 |
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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
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
kt10948@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049323
