UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Promotion of exploratory research into healthy and ocular diseases biomarkers discovery in Taiwa medical examination
Title of the study (Brief title)	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	Toru Nakazawa
Organization	Tohoku University Graduate School of Medicine
Division name	Ophthalmology
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	Hiroshi Kunikata
Organization	Tohoku University Graduate School of Medicine
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031070