UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032350 |
|---|---|
| Receipt number | R000036841 |
| Scientific Title | Analysis of the recipient cornea tissue after the corneal transplantation. |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2018/12/10 12:38:30 |
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Basic information
Public title
Analysis of the recipient cornea tissue after the corneal transplantation.
Acronym
Analysis of the recipient cornea tissue after the corneal transplantation.
Scientific Title
Analysis of the recipient cornea tissue after the corneal transplantation.
Scientific Title:Acronym
Analysis of the recipient cornea tissue after the corneal transplantation.
Region
| Japan |
Condition
Condition
The patient who underwent corneal transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate protein concentration of recipient cornea related to inflammation and examine relationship between protein and corneal disease or period from onset.
Basic objectives2
Others
Basic objectives -Others
We make a tissue sample and investigate influence of protein concentration of recipient cornea related to inflammation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein concentration of recipient cornea related to inflammation after cornea transplantation.
Key secondary outcomes
Pathological and electron microscopic study
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patient who undergo cornea transplantation in Keio University Hospital .
2.The patient who understand and agree to the study.
3.Patient over 20 years of age.
Key exclusion criteria
1.The patient who don't agree to the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Uchino |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL
03-5363-3821
hmpgx653@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Uchino |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi Shinjyuku-ku Tokyo Japan,160-8582
TEL
03-5363-3821
Homepage URL
hmpgx653@yahoo.co.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
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
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
| 2018 | Year | 05 | Month | 15 | 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 | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect recipient cornea and divide into some slice. We use one for the measurement of the inflammatory protein concentration, and use the other for a tissue sample. We examine relationship between cornea disease and operation timeand inflammatory protein concentration and histologic change.
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036841
