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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021877
Receipt No. 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

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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
Email 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
Email kenji68@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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