UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011121 |
|---|---|
| Receipt number | R000012839 |
| Scientific Title | Search for RNA Markers of Ocular Diseases |
| Date of disclosure of the study information | 2013/07/05 |
| Last modified on | 2022/01/28 22:07:15 |
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Basic information
Public title
Search for RNA Markers of Ocular Diseases
Acronym
Ocular Disease RNA Markers
Scientific Title
Search for RNA Markers of Ocular Diseases
Scientific Title:Acronym
Ocular Disease RNA Markers
Region
| Japan |
Condition
Condition
Glaucoma, Cataract, age-related macular degeneration, myopia, Corneal disease, Retinal disease, vitreous disease, infection
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is finding biomarkers of ocular diseases. It is very important for realizing early detection and early diagnosis to find the ocular disease biomarkers, which will prevent vision loss, reduce realization of unnecessary medical treatment, and effective medical treatment. Especially the disease that occupies the higher rank cause of the present halfway vision loss has many diseases which a prevalence rate increases with aging, and discovery of the new biomarker used as the key of a sick advance is desired.
Basic objectives2
Others
Basic objectives -Others
The 2nd purpose of this research is to find out the mechanism of ocular pathological conditions by grasping the molecular group to which an expression level is specifically changed for a disease. The pathology of an eye disease still has many unsolved things, and their elucidation from the new side is desired. They can become a hint for solving pathology with specific new RNA information.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Transcriptome information on ingredients, contained in biological samples from patients with ocular diseases
Key secondary outcomes
Information on ingredients other than RNA, such as protein and sugar, contained in biological samples from patients with ocular diseases
Base
Study type
Others,meta-analysis etc
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
The patients who undergo an ocular operation and the patients who consults ophthalmology at Tohoku University Hospital, because of cataract, glaucoma, corneal deceases, retinal deceases, vitreous deceases, age-related macular degeneration, infection, and high myopia.
Key exclusion criteria
none.
Target sample size
1250
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
Ophthalmology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177294
Homepage URL
http://www.oph.med.tohoku.ac.jp
kunikata@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku Universit
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-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
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
東北大学病院、東北大学大学院医学系研究科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 05 | 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
64
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
| 2012 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Molecules, including transcriptome, proteome, and so on, that obtained from patients suffered from ocular diseases , were analyzed for finding biomarkers of ocular diseases.
Management information
Registered date
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012839
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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