UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041312 |
|---|---|
| Receipt number | R000047174 |
| Scientific Title | glaucoma-related factors by quantitative protein measurement in glaucoma |
| Date of disclosure of the study information | 2020/08/05 |
| Last modified on | 2021/08/05 19:17:36 |
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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
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
satokota@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospita
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
