UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049651 |
|---|---|
| Receipt number | R000056542 |
| Scientific Title | Metabolomics analysis to discover biomarkers of glaucoma |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2022/11/30 16:47:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Metabolomics analysis to discover biomarkers of glaucoma
Acronym
Metabolomics analysis to discover biomarkers of glaucoma
Scientific Title
Metabolomics analysis to discover biomarkers of glaucoma
Scientific Title:Acronym
Metabolomics analysis to discover biomarkers of glaucoma
Region
| Japan |
Condition
Condition
Primary open-angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarkers useful for screening and stratification of glaucoma patients.
Basic objectives2
Others
Basic objectives -Others
Metabolomics analysis will be performed on plasma from glaucoma patients, and a case-control study will be conducted using data from the Tohoku Medical Megabank Organization cohort study as a control to search for biomarkers useful for screening and stratification of glaucoma patients. We will also analyze the relationship between identified metabolites and phenotypes such as intraocular pressure and visual field, and genetic polymorphisms that have been shown to be associated with glaucoma in previous genomic studies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma metabolite concentrations obtained by nuclear magnetic resonance (NMR)
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
Cases: Those diagnosed with primary open-angle glaucoma after a detailed ophthalmologic examination at Tohoku University Hospital.
Control: In the Tohoku Medical Megabank Organization cohort, subjects with no history of glaucoma and no optic nerve cupping on fundus examination.
Key exclusion criteria
As stated in the selection criteria.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Seizo |
| Middle name | |
| Last name | Koshiba |
Organization
Tohoku University
Division name
Advanced Research Center for Innovations in Next-Generation Medicine
Zip code
980-8573
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan
TEL
022-274-6016
koshiba@megabank.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University
Division name
Depertment of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7294
Homepage URL
satokota@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Medical Megabank Organization
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan
Tel
022-717-8078
tommo-ken@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research will be conducted using existing information and will be reviewed by the Ethics Committee on December 19, 2022, before starting the research using the information from Tohoku Medical Megabank Organization.
Management information
Registered date
| 2022 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056542
