UMIN-CTR Clinical Trial

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
Email	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
Email	fujita-k@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051287