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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036747
Receipt No. R000041872
Scientific Title A research for personalized medicine using integrated database of ophthalmologic, environment and multi biometric information.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/15

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Basic information
Public title A research for personalized medicine using integrated database of ophthalmologic, environment and multi biometric information.
Acronym A research for personalized medicine using integrated database of ophthalmologic, environment and multi biometric information.
Scientific Title A research for personalized medicine using integrated database of ophthalmologic, environment and multi biometric information.
Scientific Title:Acronym A research for personalized medicine using integrated database of ophthalmologic, environment and multi biometric information.
Region
Japan

Condition
Condition Healthy and subjects with eye disorders (Age:20-70) who obtain informed consent.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Ophthalmic examination, biological and environmental information acquired under unconsciousness of the subject, including genome and metabolome are constructed create integrated database. Further we aim to construct a new diagnostic and prognostic system for abnormalities of cardiovascular system and dementia such as cerebral infarction and myocardial infarction using ophthalmologic examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Usefulness of each sensor for the glaucoma patients
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who can obtain informed consent.
Key exclusion criteria Subjects who can't obtain informed consent.
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Nakazawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology,
Zip code 980-8574
Address 1-1, Seiryo-cho, Sendai-shi, Aoba-ku
TEL 022-717-7294
Email ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kazuko, Satoru, Yukihiro
Middle name
Last name Omodaka, Tsuda, Shiga
Organization Tohoku University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code 980-8574
Address 1-1, Seiryo-cho, Sendai-shi, Aoba-ku
TEL 022-717-7294
Homepage URL
Email y.shiga@oph.med.tohoku.ac.jp

Sponsor
Institute JST
Institute
Department

Funding Source
Organization JST
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 Igakubu Kenkyu kyouryoku kakari
Address 1-1, Seiryo-cho, Sendai-shi, Aoba-ku
Tel 0227178007
Email med-kenkyo@grp.tohoku.ac.jp

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 06 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
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 04 Month 24 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2019 Year 05 Month 15 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041872

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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