UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036248 |
|---|---|
| Receipt number | R000041289 |
| Scientific Title | Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers |
| Date of disclosure of the study information | 2019/03/18 |
| Last modified on | 2019/03/18 16:39:47 |
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Basic information
Public title
Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Acronym
Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Scientific Title
Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Scientific Title:Acronym
Tear Lipidome Analysis for Ophthalmic Diseases, establishment of new biomarkers
Region
| Japan |
Condition
Condition
ocular disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Biomarkers, which are indicators for objectively measuring and evaluating the physical condition of a human being, are generally made possible by blood collection and urine collection. In eye diseases, tears can be collected relatively easily, so if biomarkers in tears can be found, diagnosis can be made further non-invasively. In this study, we will analyze lipids contained in tears for the discovery of new biomarkers in eye diseases such as eye infections, eye tumors and eye allergy (lipidome analysis). We believe that biomarkers in the tears, as revealed by this study, will allow for a more non-invasive diagnosis of eye disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tears are collected with Schirmer's test paper for 5 minutes from patients who obtained informed consent at the visit to the outpatient clinic, and then comprehensive concentration measurement of extracted lipids is performed using a mass spectrometer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
At the time of outpatient visit, tears are collected for 5 minutes in Schirmer test.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
anterior segment disease
Key exclusion criteria
History of eyedrops treatment
History of eyesurgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUKINOBU |
| Middle name | |
| Last name | OKAJIMA |
Organization
Toho University omori medical center
Division name
Opthalmology
Zip code
143-8451
Address
6-11-1 omorinishi ootaku tokyo
TEL
03-3762-4151
yukinobu.okajima@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKINOBU |
| Middle name | |
| Last name | OKAJIMA |
Organization
Toho University omori medical center
Division name
Opthalmology
Zip code
143-8451
Address
6-11-1 omorinishi ootaku tokyo
TEL
03-3762-4151
Homepage URL
yukinobu.okajima@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University omori medical center
Institute
Department
Personal name
Funding Source
Organization
Toho University omori medical center
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
Toho University omori medical center
Address
6-11-1 omorinishi ootaku tokyo
Tel
03-3762-4151
yukinobu.okajima@med.toho-u.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
| 2019 | Year | 03 | Month | 18 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041289
