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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009844
Receipt No. 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

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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
Institute Department of Ophthalmology, Kyoto University Graduate School of Medicine
Institute
Department

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
URL(English) 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


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