UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054548 |
|---|---|
| Receipt number | R000062327 |
| Scientific Title | Epigenetic genetic analysis of lens epithelium and retinal proliferative membrane in ocular diseases. |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/06/03 11:41:45 |
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Basic information
Public title
Epigenetic genetic analysis of lens epithelium and retinal proliferative membrane in ocular diseases.
Acronym
Genetic analysis of lens epithelium and retinal proliferative membrane in ocular diseases
Scientific Title
Epigenetic genetic analysis of lens epithelium and retinal proliferative membrane in ocular diseases.
Scientific Title:Acronym
Genetic analysis of lens epithelium and retinal proliferative membrane in ocular diseases
Region
| Japan |
Condition
Condition
Cataract, ischemic retinal disease (including diabetic retinopathy, retinal vein occlusion, retinopathy of prematurity)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to elucidate the existence and mechanisms of epigenetic regulation of expression in the pathogenesis of ocular diseases such as diabetic eye complications and cataracts.
Basic objectives2
Others
Basic objectives -Others
Observational studies for pathological analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of genetic information obtained from collected specimens
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Must have cataracts, proliferative membranes, vitreous membranes
Key exclusion criteria
If the ophthalmologist determines that the specimen is not suitable for collection.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL
0776-61-8403
takamurayoshihiro@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takamura |
Organization
University of Fukui
Division name
department of Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL
0776-61-84-3
Homepage URL
takamurayoshihiro@gmail.com
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
Fukui University Hospital Ethics Committee
Address
23-3 Shimoaizuki Matsuoka Yoshida Fukui
Tel
0776-61-3111
takamurayoshihiro@gmail.com
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
| 2024 | Year | 06 | Month | 04 | 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
| 2015 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2040 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sample is taken at surgery and analyzed
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062327
