UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004980 |
|---|---|
| Receipt number | R000005920 |
| Scientific Title | Basic analysis of tear/aqueous humor/vitreous fluid/ retinochoroidal tissue/sclera for Chorioretinopathy |
| Date of disclosure of the study information | 2011/01/30 |
| Last modified on | 2017/03/29 06:01:39 |
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Basic information
Public title
Basic analysis of tear/aqueous humor/vitreous fluid/ retinochoroidal tissue/sclera for Chorioretinopathy
Acronym
analysis of tear/aqueous humor/Vitreous fluid/ retinochoroidal tissue/sclera
Scientific Title
Basic analysis of tear/aqueous humor/vitreous fluid/ retinochoroidal tissue/sclera for Chorioretinopathy
Scientific Title:Acronym
analysis of tear/aqueous humor/Vitreous fluid/ retinochoroidal tissue/sclera
Region
| Japan |
Condition
Condition
Chorioretinopathy(include uveitis), diabetic retinopathy, scleritis, retinal detachment, retinal vein occlusion, malignant lymphoma, epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tissue from horioretinopathy(include uveitis), diabetic retinopathy, scleritis, retinal detachment, retinal vein occlusion, malignant lymphoma, epiretinal membrane were collected during operation, which should become the useful tool for curing the disease. Collected samples were tested by several basic analysis such as real time PCR, ELISA, western blotting and tissue specimen. The sample of vitreous fluid were collected by vitrectomy with using 23 gage or 25 gage needles. The other tissue were collected by scissors. After that, laser treatment apply for spots of dissected area. We investigate the new findings and treatment for the disease that dose not have any effective treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We would not develop the drugs and new treatment method. So, we could not asses from this clinical test. We could asses and hold the clinical condition from the tissue that was collected during operation.
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 who suffered from vitreous opacification, retinal detach, the proliferative change of retina need the operation to cure those disease.
Key exclusion criteria
normal condition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuichi Maruyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1 Seiryo-machi Aobaku, Sendai
TEL
022-717-7294
maruyama-k@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuichi Maruyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1 Seiryo-machi Aobaku, Sendai
TEL
022-717-7294
Homepage URL
maruyama-k@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
RBMR-61807
Org. issuing International ID_1
Kyoto Prefectural University of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 30 | 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
We performed 87 subject of 150 scheduled subjects at Tohoku University Hospital. In our examination, we noticed that sarcoidosis and lymphoma had signature T cell and B cell population in uveitis.
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
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
The tissue collected from patients randomly and prepare for histological section, to detect the infection with using PCR, analyze the cell population. This test perform as forward looking research to detect the relationship between the results and pathogenesis.
Management information
Registered date
| 2011 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005920
