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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036248
Receipt No. 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

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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
Email 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
Email yukinobu.okajima@med.toho-u.ac.jp

Sponsor
Institute Toho University omori medical center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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