UMIN-CTR Clinical Trial

Basic information
Public title	glaucoma-related factors by quantitative protein measurement in glaucoma
Acronym	glaucoma-related factors by quantitative protein measurement in glaucoma
Scientific Title	glaucoma-related factors by quantitative protein measurement in glaucoma
Scientific Title:Acronym	glaucoma-related factors by quantitative protein measurement in glaucoma
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Use of stored samples (blood) of patients participating in "Ophthalmology Biobank (ethics committee approval: 2019-1-999)" to measure multiple proteins from blood samples of glaucoma patients and develop glaucoma The purpose of the present invention is to search for biomarkers related to the above and to create a glaucoma prediction model unique to Japanese people using the searched biomarkers.
Basic objectives2	Others
Basic objectives -Others	Search for glaucoma-related biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between the presence or absence of glaucoma and various proteins
Key secondary outcomes	1)Correlation between intraocular pressure and various proteins 2)Correlation between age/sex and various proteins 3) Correlation between visual acuity (logMAR visual acuity) and various proteins 4) Correlation between the usage of glaucoma eye drops and various proteins 5) Correlation between the presence or absence of cataract surgery and various proteins 6) Correlation between retinal morphology and various proteins by retinal optical coherence tomography 7) Correlation between various proteins and fundus blood flow by LSFG 8) Correlation between oxidative stress (dROM, BAP) and various proteins 9) Correlation between physiologically active substances and metabolites and various proteins 10) Correlation between genomic information and various proteins

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Registered in the Ophthalmology Biobank (approved by the Ethics Committee: 2019-1-999)" and blood samples are stored. Men and women aged 20 and over. The clinical data and blood sampling data obtained from those who participate in any of the approved studies below will be included in the comparative analysis.
Key exclusion criteria	none
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Nakazawa
Organization	Tohoku University Hospital
Division name	Department of Ophthalmology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7294
Email	ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person	1st name kota Middle name Last name Sato
Organization	Tohoku University Hospital
Division name	Department of Ophthalmology
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7294
Homepage URL
Email	satokota@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospita
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-3867
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

Other administrative information
Date of disclosure of the study information	2020 Year 08 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
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	2020 Year 06 Month 11 Day
Date of IRB	2020 Year 06 Month 22 Day
Anticipated trial start date	2020 Year 08 Month 05 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Search for glaucoma-related proteins

Management information
Registered date	2020 Year 08 Month 04 Day
Last modified on	2021 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047174