UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Basic analysis of tear/aqueous humor/vitreous fluid/ retinochoroidal tissue/sclera for Chorioretinopathy
Title of the study (Brief title)	analysis of tear/aqueous humor/Vitreous fluid/ retinochoroidal tissue/sclera
Region	Japan

Condition
Condition	Chorioretinopathy(include uveitis), diabetic retinopathy, scleritis, retinal detachment, retinal vein occlusion, malignant lymphoma, epiretinal membrane
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tissue from horioretinopathy(include uveitis), diabetic retinopathy, 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 vitreous fluid were collected by vitrectomy with using 23 gage or 25 gage needles. The other tissue were collected by scissors. After that, laser treatment apply for spots of dissected area. 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	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

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	The patients who suffered from vitreous opacification, retinal detach, the proliferative change of retina need the operation to cure those disease.
Key exclusion criteria	normal condition
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuichi Maruyama
Organization	Tohoku University Graduate School of Medicine
Division name	Ophthalmology
Address	1-1 Seiryo-machi Aobaku, Sendai
TEL	022-717-7294
Email	maruyama-k@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Kazuichi Maruyama
Organization	Tohoku University Graduate School of Medicine
Division name	Ophthalmology
Address	1-1 Seiryo-machi Aobaku, Sendai
TEL	022-717-7294
Homepage URL
Email	maruyama-k@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

Secondary IDs
Secondary IDs	YES
Study ID_1	RBMR-61807
Org. issuing International ID_1	Kyoto Prefectural University of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2006 Year 06 Month 01 Day
Anticipated trial start date	2006 Year 06 Month 30 Day
Last follow-up date	2017 Year 12 Month 31 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	We performed 87 subject of 150 scheduled subjects at Tohoku University Hospital. In our examination, we noticed that sarcoidosis and lymphoma had signature T cell and B cell population in uveitis.
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	2011 Year 01 Month 30 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005920