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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032350
Receipt No. 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

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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
Email 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
Email hmpgx653@yahoo.co.jp

Sponsor
Institute Keio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036841

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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