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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002449
Receipt No. R000002996
Scientific Title The study for diagnosing autoimmune retinopathy using the blood sera from the patients
Date of disclosure of the study information 2009/11/01
Last modified on 2014/02/07

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Basic information
Public title The study for diagnosing autoimmune retinopathy using the blood sera from the patients
Acronym The study for diagnosing autoimmune retinopathy
Scientific Title The study for diagnosing autoimmune retinopathy using the blood sera from the patients
Scientific Title:Acronym The study for diagnosing autoimmune retinopathy
Region
Japan

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

Objectives
Narrative objectives1 To identify the presence of circulating autoantibodies to the retina in the blood sera of some patients with suspected autoimmune retinopathy
Basic objectives2 Others
Basic objectives -Others to evaluate the presence/absence of antibodies in blood sera
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the reactivities of the blood sera from the patients or healthy volunteers against murine retina evaluated by Western blotting and immunohistochemistry
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 suspected for autoimmune retinopathy and healthy volunteers
Key exclusion criteria patients or volunteers who disagreed with participating in this study
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sentaro Kusuhara
Organization Kobe University Graduated School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6048
Email kusu@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sentaro Kusuhara
Organization Kobe University Graduated School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6048
Homepage URL
Email kusu@med.kobe-u.ac.jp

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

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 神戸大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information a case-control prospective study

Management information
Registered date
2009 Year 09 Month 05 Day
Last modified on
2014 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002996

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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