UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009844
Receipt number R000011513
Scientific Title Analysis of genotypes associated with diabetic retinopathy
Date of disclosure of the study information 2013/04/01
Last modified on 2014/02/19 16:26:00

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Basic information

Public title

Analysis of genotypes associated with diabetic retinopathy

Acronym

Analysis of genotypes associated with diabetic retinopathy

Scientific Title

Analysis of genotypes associated with diabetic retinopathy

Scientific Title:Acronym

Analysis of genotypes associated with diabetic retinopathy

Region

Japan


Condition

Condition

diabetic retinopathy, diabetes mellitus

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Searching for genetic polymorphisms associated with diabetic retinopathy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

genetic polymorphisms which are statistically significantly associated with diabetic retinopathy

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with diabetic retinopathy, and patients with diabetes mellitus but without diabetic retinopathy

Key exclusion criteria

pregnant and parturient women

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagahisa Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

54 Shogoinkawaharacho, Sakyo-ku, Kyoto 606-8507 Japan

TEL

075-751-3250

Email

nagaeye@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriyuki Unoki

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto

TEL

075-751-3250

Homepage URL


Email

nunoki@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

京都大学医学部附属病院眼科


Other administrative information

Date of disclosure of the study information

2013 Year 04 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

Enrolling by invitation

Date of protocol fixation

2013 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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

The purpose of this study is to search genetic polymorphisms associated with diabetic retinopathy


Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2014 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011513


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name