UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039800 |
|---|---|
| Receipt number | R000045391 |
| Scientific Title | Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/03/12 23:11:55 |
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Basic information
Public title
Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Acronym
Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Scientific Title
Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Scientific Title:Acronym
Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Region
| Japan |
Condition
Condition
1.Diabetes and its complications
2.Vascular diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop risk indicators related to the onset, severity and prognosis of diabetic complications and various vascular diseases
Basic objectives2
Others
Basic objectives -Others
To develop an artificial intelligence algorithm to predict the risk of various vascular diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors associated with the development and progression of various vascular diseases
Key secondary outcomes
1.Factors associated with the presence, disease subtype, severity, and treatment response of various vascular diseases
2.Factors associated with ocular blood flow
3.Factors associated with the levels of HbA1c
4.Factors associated with nail bed capillaries
5.Factors associated with the degree of oxidative stress
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diabetes and its complications
2. Fundus diseases other than diabetic retinopathy
3. Uveitis
4. Lifestyle-related diseases other than diabetes and obesity without diabetes
5. Cardio-cerebrovascular disease
6. Cataract, epiretinal membrane, macular hole, hypertension, dyslipidemia without the above diseases
Key exclusion criteria
Patients who disagreed with participating this study.
Target sample size
7000
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
Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Yasuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL
022-717-7294
Homepage URL
myasuda@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
Tel
022-717-8007
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
| 2020 | Year | 05 | 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
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to identify biomarkers of vascular diseases in various organs throughout the body, mainly for diabetic complications. We will analyze biosamples and non-invasive vascular imaging data for this purpose.
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045391
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
