UMIN-CTR Clinical Trial

Basic information
Public title	Discover of disease-susceptibility genes of ocular disease
Acronym	SNPs of ocular diseases
Scientific Title	Discover of disease-susceptibility genes of ocular disease
Scientific Title:Acronym	SNPs of ocular diseases
Region	Japan

Condition
Condition	Ocular disease patients and healthy volunteers
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Discover of disease-susceptibility genes of ocular diseases.
Basic objectives2	Others
Basic objectives -Others	SNPs of ocular diseases
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Revealing disease-susceptibility genes of ocular disease
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Ocular disease patients and healthy volunteers (2)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria	Other conditions considered inappropriate by attending physician
Target sample size	4000

Research contact person
Name of lead principal investigator	1st name Kubota Middle name Last name Toshiaki
Organization	Oita University Faculty of Medicine
Division name	Department of Ophthalmology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
TEL	097-586-5904
Email	oita_oph-admin@umin.ac.jp

Public contact
Name of contact person	1st name Nakano Middle name Last name Satoko
Organization	Oita University Faculty of Medicine
Division name	Department of Ophthalmology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
TEL	097-586-5904
Homepage URL
Email	oita_oph-admin@umin.ac.jp

Sponsor
Institute	Department of Ophthalmology, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Foundation TENSHINDO Oita Prefectural Hospital Shinbeppu Hospital BEPPU Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Human Genome, Gene Analysis Research Ethics Committee, Oita University Faculty of Medicine
Address	1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
Tel	097-586-5110
Email	syomu@oita-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	大分大学医学部附属病院(大分県) 天心堂へつぎ病院(大分県) 大分県立病院(大分県) 新別府病院(大分県) 別府医療センター(大分県)

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 01 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	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 01 Day
Date of IRB	2012 Year 11 Month 16 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	SNPs of ocular disease

Management information
Registered date	2013 Year 08 Month 24 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013536