UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021778 |
|---|---|
| Receipt number | R000025116 |
| Scientific Title | An exploratory research for biomarker and drug discovery seeds based on glaucoma database |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2016/04/04 21:34:58 |
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Basic information
Public title
An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Acronym
An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Scientific Title
An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Scientific Title:Acronym
An exploratory research for biomarker and drug discovery seeds based on glaucoma database
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To aggregate analysis using clinical and biological information obtained with our previous research.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To aggregate analysis using clinical and biological information obtained with our previous research.
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Glaucomatous optic change
2) Visual field defects, comfirmed in at least two visula field examinations, for glaucoma. Visual field within the normal limits for preperimetric glaucoma
3) Patients who give written informed consent
Key exclusion criteria
1) Patients who unable to be accepted by doctor
2) Patients who unable to measure intraocular pressure
3) Patients with unable to assess ocular fundus due to corneal or lens opacity
4) Patients with poorly understand the study and unable to give written informed consent.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishiguchi KM |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL
022-717-7294
nishiguchi@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Shiga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
TEL
022-717-7294
Homepage URL
y.shiga@oph.med.tohoku.ac.jp
Sponsor or person
Institute
No institute
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 03 | Month | 31 | 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
| 2015 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An aggregate analysis of clinical and biological data obtained with our previous research in ongoing.
Management information
Registered date
| 2016 | Year | 04 | Month | 04 | Day |
Last modified on
| 2016 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
