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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003513
Receipt No. R000004257
Scientific Title The relationship between the stage of diabetic retinopathy and the concentration of serum cytokines
Date of disclosure of the study information 2010/07/01
Last modified on 2010/04/20

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Basic information
Public title The relationship between the stage of diabetic retinopathy and the concentration of serum cytokines
Acronym The relationship between the stage of diabetic retinopathy and the concentration of serum cytokines
Scientific Title The relationship between the stage of diabetic retinopathy and the concentration of serum cytokines
Scientific Title:Acronym The relationship between the stage of diabetic retinopathy and the concentration of serum cytokines
Region
Japan

Condition
Condition diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine if there is any correlation between the stage of diabetic retinopathy and the concentration of serum cytokine, especially in insulin-like growth factor 2
Basic objectives2 Others
Basic objectives -Others To elucidate the mechanism for the progression of diabetic retinopathy
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The concentration of serum cytokine in diabetic patients
Key secondary outcomes The concentration of serum cytokine in healthy adults

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 10ml of blood sampling
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 1, Diabetic patients

2, Healthy adults as a control group
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanori Imia
Organization Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 7-5-2, kusunoki-cho, chuo-ku, kobe, Japan
TEL 078-382-6048
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisanori Imai
Organization Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 7-5-2, kusunoki-cho, chuo-ku, kobe, Japan
TEL 078-382-6048
Homepage URL
Email

Sponsor
Institute Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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 神戸大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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

Management information
Registered date
2010 Year 04 Month 20 Day
Last modified on
2010 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004257

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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