UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008609 |
|---|---|
| Receipt number | R000010120 |
| Scientific Title | Analysis of T cell mediated immune responses in cytomegalovirus-related intraocular inflammatory diseases |
| Date of disclosure of the study information | 2012/08/03 |
| Last modified on | 2012/12/20 18:36:48 |
* 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
Analysis of T cell mediated immune responses in cytomegalovirus-related intraocular inflammatory diseases
Acronym
Analysis of T cell mediated immune responses in cytomegalovirus-related intraocular inflammatory diseases
Scientific Title
Analysis of T cell mediated immune responses in cytomegalovirus-related intraocular inflammatory diseases
Scientific Title:Acronym
Analysis of T cell mediated immune responses in cytomegalovirus-related intraocular inflammatory diseases
Region
| Japan |
Condition
Condition
idiopathic corneal endotheliitis
Cytomegalovirus corneal endotheliitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze roles and profile of cytomegalovirus (CMV)-specific memory T cells in pathogenesis of CMV-related intraocular inflammatory diseases.
Basic objectives2
Others
Basic objectives -Others
Immunological responses
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Profile and effector activity of CMV-specific memory T cells
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
Patients diagnosed as CMV-related intraocular inflammatory disease based on clinical characteristics and CMV specific real-time PCR are enrolled. Healthy subjects are studied as control.
Key exclusion criteria
Subjects without prior informed consent to enrollment to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Inoue |
Organization
Faculty of Medicine ,Tottori University
Division name
Division of ophthalmology and Visual Science
Zip code
Address
36-1,Nishi-cho,Yonago City,
TEL
+81-859-38-6617
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Miyazaki |
Organization
Faculty of Medicine,Tottori University
Division name
Division of ophthalmology and Visual Science
Zip code
Address
36-1,Nishi-cho,Yonago City,
TEL
+81-859-38-6617
Homepage URL
dm@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine ,Tottori University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine,Tottori University
Division of ophthalmology and Visual Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
鳥取大学医学部附属病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CMV-specific lymphocytes were collected for what was the specific HLA of the eligible patients, we investigate the differences of immune profile between CMV endotheliitis patients and normal subjects.
Management information
Registered date
| 2012 | Year | 08 | Month | 03 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010120
