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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021778
Receipt No. R000025116
Scientific Title An exploratory research for biomarker and drug discovery seeds based on glaucoma database 
Date of disclosure of the study information 2019/03/31
Last modified on 2016/04/04

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Basic information
Public title An exploratory research for biomarker and drug discovery seeds based on glaucoma database 
Acronym An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Scientific Title An exploratory research for biomarker and drug discovery seeds based on glaucoma database 
Scientific Title:Acronym An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To aggregate analysis using clinical and biological information obtained with our previous research.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To aggregate analysis using clinical and biological information obtained with our previous research.
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
0 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1) Glaucomatous optic change
2) Visual field defects, comfirmed in at least two visula field examinations, for glaucoma. Visual field within the normal limits for preperimetric glaucoma
3) Patients who give written informed consent
Key exclusion criteria 1) Patients who unable to be accepted by doctor
2) Patients who unable to measure intraocular pressure
3) Patients with unable to assess ocular fundus due to corneal or lens opacity
4) Patients with poorly understand the study and unable to give written informed consent.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishiguchi KM
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL 022-717-7294
Email nishiguchi@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Shiga
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL 022-717-7294
Homepage URL
Email y.shiga@oph.med.tohoku.ac.jp

Sponsor
Institute No institute
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information An aggregate analysis of clinical and biological data obtained with our previous research in ongoing.

Management information
Registered date
2016 Year 04 Month 04 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025116

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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