UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036747 |
|---|---|
| Receipt number | 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 | 2021/05/12 14:59:06 |
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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
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
y.shiga@oph.med.tohoku.ac.jp
Sponsor or person
Institute
JST
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041872
