UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic analysis of cornea/sclera in cornea, sclera disease and Chorioretinopathy
Title of the study (Brief title)	analysis of cornea and scleral tissue
Region	Japan

Condition
Condition	cornea, sclera disease and chrioretinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tissue from horioretinopathy(include uveitis), diabetic retinopathy, cornea disease, 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 cornea and sclera were collected by scissors. 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
Trial characteristics_2
Developmental phase

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	over 20 year old (if patient need for diagnosis, age should not be mattered. Parents should sing for the agreement form) cornea and sclera disease with informed consent and agreement
Key exclusion criteria	with severe disease
Target sample size	120

Research contact person
Name of lead principal investigator	Kazuichi Maruyama
Organization	Tohoku University Hospital
Division name	ophthalmology
Address	1-1 Seiryo-machi Aoba ward, Sendai
TEL	+81-22-717-7294
Email	maruyama-k@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Kazuichi Maruyama
Organization	Tohoku University Hospital
Division name	Ophthalmology
Address	1-1 Seiryo-machi Aoba ward, Sendai
TEL	+81-22-717-7294
Homepage URL
Email	maruyama-k@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	京都府立医科大学 理化学研究所 ＬＳＩメディエンス

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 02 Day
Anticipated trial start date	2016 Year 02 Month 02 Day
Last follow-up date	2017 Year 12 Month 01 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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	2016 Year 02 Month 25 Day
Last modified on	2016 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024453