UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051753 |
|---|---|
| Receipt number | R000059066 |
| Scientific Title | Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease |
| Date of disclosure of the study information | 2023/07/30 |
| Last modified on | 2024/04/08 16:13:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease
Acronym
Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease
Scientific Title
Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease
Scientific Title:Acronym
Longitudinal analysis of exophthalmos in Japanese people with/without autoimmune thyroid disease
Region
| Japan |
Condition
Condition
Autoimmune thyroid disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the differences in the severity of exophthalmos in Japanese patients with autoimmune thyroid disease depend on whether a patient has a severe myopia,or histories of somoking and/or steroid use. We also evaluate exophthalmos in Japanese people without autoimmune thyroid disease to determine the normal range of exophthalmos in Japanese people.
Basic objectives2
Others
Basic objectives -Others
We evaluate the differences in the severity of exophthalmos in Japanese patients with autoimmune thyroid disease depend on whether a patient has a severe myopia,or histories of somoking and/or steroid use. We also evaluate exophthalmos in Japanese people without autoimmune thyroid disease to determine the normal range of exophthalmos in Japanese people.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exophthalmos determined by Hertel's ptectometer.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with autoimmune thyroid disease(Graves disease and Hashimoto thyroiditis)
2) People without autoimmune thyroid disease
Key exclusion criteria
Patient with histories of ophthic surgery.
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1Sakamoto, Nagasaki
TEL
0958197262
horie@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Horie |
Organization
Nagasaki University
Division name
Endocrinology and Metabolism
Zip code
8528501
Address
1-7-1Sakamoto, Nagasaki
TEL
0958197262
Homepage URL
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Review board of clinical research at Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
0958197262
horie@nagasaki-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
| 2023 | Year | 07 | Month | 30 | 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
| 2023 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059066
