UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027114 |
|---|---|
| Receipt number | 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 20:22:15 |
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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
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
kunikata@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine.
Department of Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031070
