UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003513
Receipt number 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 20:22:29

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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