UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005851 |
|---|---|
| Receipt number | R000006911 |
| Scientific Title | Immunohistchemistry of proliferative membrane and enzyme linked immunosorbent assay of proliferative factor of vitreus fluid in eye proliferation disease |
| Date of disclosure of the study information | 2011/06/27 |
| Last modified on | 2011/06/27 00:02:20 |
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Basic information
Public title
Immunohistchemistry of proliferative membrane and enzyme linked immunosorbent assay of proliferative factor of vitreus fluid in eye proliferation disease
Acronym
Investigation of proliferative factor in eye proliferation disease
Scientific Title
Immunohistchemistry of proliferative membrane and enzyme linked immunosorbent assay of proliferative factor of vitreus fluid in eye proliferation disease
Scientific Title:Acronym
Investigation of proliferative factor in eye proliferation disease
Region
| Japan |
Condition
Condition
proliferative diabetic retinopathy
proliferative vitreoretinopathy
epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
determination of proliferative factor in eye proliferation disease and investigation of localization of proliferative factor in eye proliferation disease
Basic objectives2
Others
Basic objectives -Others
several proliferative factors were not investigated in proliferative membrane.
Reports that investigation of votreus fluid and proliferative membrane in according to the disease were scarce.
Therefore, several factors are examined by using the proliferative membrane and vitreus fluid.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
localization of proliferative factor and concentration of proliferative factor in vitreus fluid
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
The patients with eye proliferation disease indicated in vitrectomy
Key exclusion criteria
A case of the patient do not consent that participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | akira shiono |
Organization
st marianna university school of medicine
Division name
depertment of ophthalmology
Zip code
Address
sugao miyamae ward kawasaki city 2-16-1
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | akira shiono |
Organization
st marianna university school of medicine
Division name
depertment of ophthalmology
Zip code
Address
sugao miyamae ward kawasaki city 2-16-1
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
department of ophthalmology
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
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
聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
extract samples from 15 patients
Management information
Registered date
| 2011 | Year | 06 | Month | 27 | Day |
Last modified on
| 2011 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006911
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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