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

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 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


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

Value
https://center6.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