UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032946 |
|---|---|
| Receipt number | R000011589 |
| Scientific Title | Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration, diabetic retinopathy, and central serous chorioretinopathy |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2021/06/13 16:54:46 |
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Basic information
Public title
Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Acronym
Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Scientific Title
Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Scientific Title:Acronym
Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Region
| Japan |
Condition
Condition
age-related macular degeneration, diabetic retinopathy, central serous chorioretinopathy
Classification by specialty
| Ophthalmology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship of the serum cytokine levels, fatty acid, and oxidation products with age-related macular degeneration and diabetic retinopathy, and central serous chorioretinopathy
Basic objectives2
Others
Basic objectives -Others
serum cytokine levels, fatty acid, and oxidation products
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
serum levels of cytokine , fatty acid, and oxidation products and patients age, severity of the diseases
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
| 50 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with age-related macular degeneration or diabetic retinopathy
central serous chorioretinopathy
control: Patients without age-related macular degeneration, diabetic retinopathy, and any other inflammatory diseases.
Key exclusion criteria
Patient intaking Omega-3 supplements or medications
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Hospital Dept. of Ophthalmology
Division name
Ophthalmology
Zip code
4668550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
Homepage URL
http://www.med.nagoya-u.ac.jp/ganka/
h-kaneko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Dept. of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Nagoya University Hospital
Address
65 Tsurumai, Showa-ku, Nagoya
Tel
052-744-2061
ethics@med.nagoya-u.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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
na
Management information
Registered date
| 2018 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011589
| 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 |
