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

* 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

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 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


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

Value
https://center6.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