UMIN-CTR Clinical Trial

Basic information
Public title	Analysis o expression level of genes and proteins in the cornea
Acronym	Analysis o expression level of genes and proteins in the cornea
Scientific Title	Analysis o expression level of genes and proteins in the cornea
Scientific Title:Acronym	Analysis o expression level of genes and proteins in the cornea
Region	Japan Europe

Condition
Condition	Analysis o expression level of genes and proteins in the cornea
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis o expression level of genes and proteins in the cornea
Basic objectives2	Others
Basic objectives -Others	Analysis o expression level of genes and proteins in the cornea
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis o expression level of genes and proteins in the cornea
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Fuchs corneal endothelial dystrophy
Key exclusion criteria	Patients who do not wish to provide sample
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Okumura
Organization	Doshisha University
Division name	Department of Biomedical Engineering
Zip code	610-0394
Address	1-3 tatara MIyakodani, Kyotanabe, Japan
TEL	0774656508
Email	nokumura@mail.doshisha.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Okumura
Organization	Doshisha University
Division name	Department of Biomedical Engineering
Zip code	610-0394
Address	1-3 tatara MIyakodani, Kyotanabe, Japan
TEL	0774656508
Homepage URL
Email	nokumura@mail.doshisha.ac.jp

Sponsor
Institute	Doshisha University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology, MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB
Address	1-3 tatara MIyakodani, Kyotanabe, Japan
Tel	075-251-3158
Email	ji-rinri@mail.doshisha.ac.jp

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	2021 Year 02 Month 04 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	2021 Year 01 Month 27 Day
Date of IRB	2021 Year 01 Month 27 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2021 Year 02 Month 04 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049354