UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055754 |
|---|---|
| Receipt number | R000063720 |
| Scientific Title | Exploration and establishment of predictive markers of intravenous glucocorticoids response in active thyroid eye disease |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2024/10/06 11:26:48 |
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Basic information
Public title
Exploration and establishment of predictive markers of intravenous glucocorticoids response in active thyroid eye disease
Acronym
Exploration and establishment of predictive markers of intravenous glucocorticoids response in active thyroid eye disease
Scientific Title
Exploration and establishment of predictive markers of intravenous glucocorticoids response in active thyroid eye disease
Scientific Title:Acronym
Exploration and establishment of predictive markers of intravenous glucocorticoids response in active thyroid eye disease
Region
| Japan |
Condition
Condition
thyroid eye disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish biomarkers to predict treatment response in active thyroid eye disease requiring treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After 24 weeks, we will search for differentially expressed proteins by comprehensive proteomic using pretreatments sera of responders with CAS improvement (improvement of 2 or more points or decrease to less than 3 points) and other non responders.
Once candidate proteins are identified, the number of cases will be increased and the ELISA method will be used for confirmation and validation.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases diagnosed as active thyroid eye disease.
Key exclusion criteria
Cases in which the physician in charge considers the patient ineligible for enrollment in the study
Target sample size
35
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
Nishicho 36-1, Yonago, Tottori, Japan
TEL
0859-38-6512
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
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6512
Homepage URL
k.matsuzawa@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
Kazuhiko Matsuzawa
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Tottori
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Faculty of Medicine
Address
36-1, Nishi-cho, Yonago, Tottori
Tel
0859-38-6512
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
| 2025 | Year | 10 | Month | 01 | 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
66
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-treatment sera of patients with active thyroid eye disease will be stored and divided into two groups (responder and non-responder) according to treatment response after 24 weeks, and the pre-treatment sera will be used to search for predictive markers of response to treatment.
Management information
Registered date
| 2024 | Year | 10 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063720
