UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021877 |
|---|---|
| Receipt number | R000025222 |
| Scientific Title | Basic analysis of vitreous fluid and retina for chorioretinal disorders |
| Date of disclosure of the study information | 2016/04/14 |
| Last modified on | 2016/04/11 22:45:12 |
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Basic information
Public title
Basic analysis of vitreous fluid and retina for chorioretinal disorders
Acronym
Basic analysis of vitreous fluid and retina
Scientific Title
Basic analysis of vitreous fluid and retina for chorioretinal disorders
Scientific Title:Acronym
Basic analysis of vitreous fluid and retina
Region
| Japan |
Condition
Condition
chorioretinal disorders includins uveitis, retinal detachment, or diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathogenesis of chorioretinal disorders by the analysis of ocular tissues.
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Inflammatory cytokine levels, flow cytometric analysis, PCR, and immunohistochemical analysis of intraocular tissues.
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 with chorioretinal disorders includins uveitis, retinal detachment, or diabetic retinopathy.
Key exclusion criteria
Patients who is determined inappropriate to participate in this study by attending physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Sotozono |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto city, Kyoto 602-0841, Japan
TEL
075-251-5578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Nagata |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto city, Kyoto 602-0841, Japan
TEL
075-251-5578
Homepage URL
kenji68@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 14 | 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
We demonstrated that CD4/CD8 ratio of vitreous-infiltrating lymphocytes has high diagnostic value in ocular sarcoidosis.
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
| 2011 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025222
