UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054544 |
|---|---|
| Receipt number | R000062312 |
| Scientific Title | Clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/06/02 00:16:14 |
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Basic information
Public title
Clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic
Acronym
Clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic
Scientific Title
Clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic
Scientific Title:Acronym
Clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic
Region
| Japan |
Condition
Condition
Thyroid associated ophthalmopathy
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate about clinical features and therapeutic response of thyroid associated ophthalmopathy during COVID-19 pandemic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical features at diagnosis
therapeutic response of clinical activity score and diplopia at 6 months after
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients from 20 to 90 years old diagnosed with active thyroid associated ophthalmopathy
Key exclusion criteria
Patients who have indicated their refusal to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Matsuzawa |
Organization
Tottori University Faculty of Medicine
Division name
Division of Pharmacology
Zip code
683-8504
Address
Nishi-cho36-1, Yonago, Tottori
TEL
+81-859-38-6517
k.matsuzawa@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Matsuzawa |
Organization
Tottori University Faculty of Medicine
Division name
Division of Pharmacology
Zip code
683-8504
Address
Nishi-cho36-1, Yonago, Tottori
TEL
+81-859-38-6517
Homepage URL
k.matsuzawa@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Tottori University Faculty of Medicine
Address
Nishi-cho36-1, Yonago, Tottori
Tel
+81-859-38-6517
k.matsuzawa@tottori-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
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients from January, 2013 to December 2019 were included as pre-COVID-19 patients. Ophthalmologic, MRI, and blood test findings were compared for patients during COVID-19 pandemic as cases after January 2020. Because this was a retrospective observational study, participation in the study was opt-out and widely publicized.
Management information
Registered date
| 2024 | Year | 06 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062312
