UMIN-CTR Clinical Trial

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
Email	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
Email	kunikata@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012839