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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027114
Receipt No. R000031070
Scientific Title Promotion of exploratory research into healthy and ocular diseases biomarkers discovery in Taiwa medical examination
Date of disclosure of the study information 2017/04/24
Last modified on 2017/04/24

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Basic information
Public title Promotion of exploratory research into healthy
and ocular diseases biomarkers discovery in Taiwa medical examination
Acronym Healthy and ocular diseases biomarkers discovery
Scientific Title Promotion of exploratory research into healthy
and ocular diseases biomarkers discovery in Taiwa medical examination
Scientific Title:Acronym Healthy and ocular diseases biomarkers discovery
Region
Japan

Condition
Condition Subjects received Taiwa medical examination.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate normal range for various biomarkers, including genome, protein, oxidative stress, ocular structure, blood flow and visual field for subjects received Taiwa medical examination.
Basic objectives2 Others
Basic objectives -Others To analyze bioactive compound, cytokines, proteome, metabolome, nucleic acid, autoantibodiesa and oxidative stress in blood and urine samples.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To determine the normal range of various ocular parameters, including visual acuity, refractive error, OCT, Humphrey Frequency Doubling Technology Perimetry, IOL master, Laser speckle flowgraphy.
Key secondary outcomes To analyze bioactive compound, cytokines, proteome, metabolome, nucleic acid, autoantibodiesa and oxidative stress in blood and urine samples.

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
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Having written consent for participation in this study.
Key exclusion criteria Subjects who do not consent in this study.
Target sample size 600

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

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kunikata
Organization Tohoku University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai city, Miyagi, Japan
TEL 022-717-7294
Homepage URL
Email kunikata@oph.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine.
Department of Ophthalmology
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 24 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
2017 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate normal range for various biomarkers, including genome, protein, oxidative stress, ocular structure, blood flow and visual field for subjects received Taiwa medical examination.
In addition, we analyze bioactive compound, cytokines, proteome, metabolome, nucleic acid, autoantibodiesa and oxidative stress in blood and urine samples.

Management information
Registered date
2017 Year 04 Month 24 Day
Last modified on
2017 Year 04 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031070

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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