UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029494 |
|---|---|
| Receipt number | R000021075 |
| Scientific Title | Acquired immune response to cytomegalovirus in corneal endotheliitis |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2018/10/12 09:55:11 |
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Basic information
Public title
Acquired immune response to cytomegalovirus in corneal endotheliitis
Acronym
Acquired immune response to CMV in corneal endotheliitis
Scientific Title
Acquired immune response to cytomegalovirus in corneal endotheliitis
Scientific Title:Acronym
Acquired immune response to CMV in corneal endotheliitis
Region
| Japan |
Condition
Condition
corneal endotheliitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the cause of cytomegalovirus corneal endotheliitis is unknown. since it develop in non immunocompromised patient, immune mechanism involved in CMV seems to be in a special state. what is more, CMV T cell epitope is shown to be responsible for idiopathic corneal endotheliitis. we try to illustrate the mechanism from perspective of activation of epitope-specific acquired immunity.
Basic objectives2
Others
Basic objectives -Others
pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
antigen-specific CD8+ T cell ratio and cytokine profile.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
corneal endotheliitis patient and healthy person as control.
Key exclusion criteria
patient did not give written informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MIYAZAKI Dai |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6617
dm@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIYAZAKI Dai |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6617
Homepage URL
dm@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university Division of Ophthalmology and Visual Science
Institute
Department
Personal name
Funding Source
Organization
Tottori university Division of Ophthalmology and Visual Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 10 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the difference in immune response to cytomegalovirus in patients with corneal endothelitis and healthy subjects.
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021075
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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