UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044906 |
|---|---|
| Receipt number | R000051287 |
| Scientific Title | Analysis of molecular pathology on diseases that cause retinal degeneration and retinal dysfunction |
| Date of disclosure of the study information | 2021/07/19 |
| Last modified on | 2021/07/19 15:33:14 |
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Basic information
Public title
Analysis of molecular pathology on diseases that cause retinal degeneration and retinal dysfunction
Acronym
Molecular pathology analysis of retinal dysfunction
Scientific Title
Analysis of molecular pathology on diseases that cause retinal degeneration and retinal dysfunction
Scientific Title:Acronym
Molecular pathology analysis of retinal dysfunction
Region
| Japan | Europe |
Condition
Condition
retinal degeneration, retinal dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the genetic causes and molecular pathology of retinal degeneration and retinal dysfunction by omics analysis based on DNA and RNA analysis by next-generation sequencing.
Basic objectives2
Others
Basic objectives -Others
not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of pathogenic mutations.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with retinal degeneration/retinal dysfunction presumably caused by genetic defects
Key exclusion criteria
Failed to obtain consent.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Fujita |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65, Turumai-cho, Syowa-ku, Nagoya-shi, Aichi-ken
TEL
052-744-2275
fujita-k@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Fujita |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65, Turumai-cho, Syowa-ku, Nagoya-shi, Aichi-ken
TEL
052-744-2275
Homepage URL
fujita-k@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
nstitutional Review Boards of Nagoya University Hospital
Address
65, Turumai-cho, Syowa-ku, Nagoya-shi, Aichi-ken
Tel
052-744-2973
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 19 | 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
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | 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
Mainly patients with suspected retinal dysfunction examined at our institute during March 2021- March 2029 will be studied.
For diagnosis, fundus photo, OCT, visual field, visual acuity, electroretinogram, fundus autofluorescence will be examined.
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051287
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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