UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020718 |
|---|---|
| Receipt number | R000023907 |
| Scientific Title | Intraocular fluid composition analysis |
| Date of disclosure of the study information | 2016/01/24 |
| Last modified on | 2023/06/06 09:16:10 |
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Basic information
Public title
Intraocular fluid composition analysis
Acronym
Intraocular fluid composition analysis
Scientific Title
Intraocular fluid composition analysis
Scientific Title:Acronym
Intraocular fluid composition analysis
Region
| Japan |
Condition
Condition
All cases to pierce the surgical instruments or injection needle into the eye for therapeutic purposes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consider the relationship between intraocular fluid composition and the ophthalmic disease or therapeutic response.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Beta NGF/NGFB, IL-15, CD40 ligand, IL-16/LCF, EGF, IL-17A/CTLA8, ENA-78/CXCL5, IL-17F/ML-1, Eotaxin/CCL11, IL-20, FGF basic, IP-10/CXCL10, Fractalkine, ITAC/CXCL11, G-CSF/CSF-3, Leptin/LEP, GM-CSF/CSF-2, MCP-1/CCL2, GRO alpha/CXCL1, MCP-3/CCL7, IFN alpha2, MCSF/CSF-1, IFN beta, MIG/CXCL9, IFN gamma, MIP-1 alpha/CCL3, IL-1 alpha, MIP-1 beta/CCL-4, IL-1 beta, MIP-3 alpha/CCL20, IL-1RA/IL1R1, PAI-1/Serpin E1, IL-2, PDGFBB, IL-4, RANTES/CCL5, IL-5, Resistin/ADSF, IL-6, SAA, IL-7, TGF alpha, IL-8/CXCL8, TGF beta1, IL-9, TNF alpha, IL-10/CSIF, TNF beta, IL-12( p40), TRAIL/TNFSF10, IL-12(p70), VEGF-A, IL-13, Adiponectin, IL-31, BDNF, LIF, BLC/CXCL13, MIF, BlyS/BAFF/CD257, MPO, CTACK/CCL27, OPG, E-selectin/CD62E, OSM, Eotaxin2/CCL24, PIGF-1, Eotaxin3/CCL26, RANKL/TNFSF11, FAS/TNFRSF6, SAP/Pentraxin2, FAS Ligand/TNFSF6, SCF/MGF, Granzyme B, SCGF-beta/CLEC11A, ICAM-1/CD54, SDF-1/CXCL12, IFN omega/IFNW1, SLP1, IL-2 RA/CD25, Survivin/BIRC5, IL-3, TNFRI/TNFRSF1A, IL-21, TNFRII/TNFRSF1B, IL-22/IL-TIF, TPO/Thrombopoietin, IL-23 p19, TSLP, IL-27, VCAM-1/CD106, IL-29, MMP-1, MMP-3, MMP-7, MMP-8, MMP-9, MMP-12, MMP-13, IL-6, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-33,P-Selectin/CD62, sCD40L, total IgG, rubella IgG, tronbin, lipid mediator SIP,ATX,LPA,LPC, Th1/Th2, Aflibercept, Brolucizumab, farisimab, ranibizumab, bevacizumab
Key secondary outcomes
clinical course
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
It is necessary to perform surgery or injection to the eye.
Key exclusion criteria
Without informed consent.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
0285-58-7382
takahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Ophthalmology
Zip code
329-0431
Address
3311-1 Yakushiji Shimotsuke-shi Tochigi
TEL
0285-58-7382
Homepage URL
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
JCHO Tokyo Shinjuku Medical Center, Yokohama Minami Kyousai Hospital,Nihon University itabashi Hospital,Haga Red Cross Hospital,The University of Tokyo Hospital,The University of Brescia
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-7550
rinri@jichi.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
自治医科大学附属病院（栃木県）、JCHO東京新宿メディカルセンター（東京都）、横浜南共済病院（神奈川県）、日本大学医学部附属板橋病院（東京都）、芳賀赤十字病院（栃木県）、東京都医学部附属病院（東京都）、The University of Brescia（イタリア）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Terao R, et al Graefes Arch Clin Exp Ophthalmol 2023
Kimura N, et al Transl Vis Sci Technol 2022
Inoda S, et al Graefes Arch Clin Exp Ophthalmol 2021
Hayashi T, et al Sci Rep 2021
Arai Y, et al PloS one 2020
Sakamoto S, et al Br J Ophthalmol 2018
Nomura Y, et al Retina 2016
Nomura Y, et al Graefes Arch Clin Exp Ophthalmol 2016
Takahashi H, et al Br J Ophthalmol 2016
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
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
| 2013 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control study. Subjects: all patients fit to inclusion criteria and visited our hospitals from Jul 2013 to Mar 2019.
Management information
Registered date
| 2016 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023907
| 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 |
