UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056712 |
|---|---|
| Receipt number | R000064827 |
| Scientific Title | Exploring the effects of orbital diseases on intraorbital tissues |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/14 17:08:33 |
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Basic information
Public title
Exploring the effects of orbital diseases on intraorbital tissues
Acronym
Exploring the effects of orbital diseases on intraorbital tissues
Scientific Title
Exploring the effects of orbital diseases on intraorbital tissues
Scientific Title:Acronym
Exploring the effects of orbital diseases on intraorbital tissues
Region
| Japan |
Condition
Condition
orbital disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the pathology of orbital diseases on the orbital tissue from the perspective of histology and biochemistry. We will also clarify the relationship between the severity of orbital diseases and these factors.
Basic objectives2
Others
Basic objectives -Others
Concentration of fibrosis markers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of inflammatory cytokines in orbital tissue
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing orbital surgery
Key exclusion criteria
Patients who have not reached the appropriate age
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
h.shimizu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Nagoya University
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
Homepage URL
h.shimizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Nagoya University
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
Nagoya University
Address
65 Tsurumai, Showa-ku, Nagoya
Tel
052-744-2277
h.shimizu@med.nagoya-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 | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064827
