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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020877
Receipt No. R000024089
Scientific Title Diagnostic efficacy of cell block preparation in intraocular lymphoma
Date of disclosure of the study information 2016/02/04
Last modified on 2017/02/26

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Basic information
Public title Diagnostic efficacy of cell block preparation in intraocular lymphoma
Acronym Cell block in intraocular lymphoma
Scientific Title Diagnostic efficacy of cell block preparation in intraocular lymphoma
Scientific Title:Acronym Cell block in intraocular lymphoma
Region
Japan

Condition
Condition intraocular lymphoma
Classification by specialty
Ophthalmology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to analyze the usefulness of the cell block method for diagnosis of intraocular lymphoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of positive rates in cell block methods of vitreous infusion specimens obtained during vitrectomy
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 Cases diagnosed with intraocular lymphoma based on clinical and laboratory findings
Key exclusion criteria Uveitis patients definitely diagnosed by clinicopathological examinations such as for Behcets disease, sarcoidosis, Harada disease, viral uveitis, acute retinal necrosis, infectious/post operative endophthalmitis, tuberculosis, and syphilis were excluded from this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kase Satoru
Organization Hokkaido University
Division name Ophthalmology
Zip code
Address N14 W5
TEL 011-706-5944
Email kaseron@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kase Satoru
Organization Hokkaido University
Division name Ophthalmology
Zip code
Address N14 W5
TEL 011-706-5944
Homepage URL
Email kaseron@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University, Department of Ophthalmology
Institute
Department

Funding Source
Organization an unrestricted grant of the Young Investigation award from the Japanese Ocular Inflammation Society.
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Positive rate in cell block method reached over 93%. This study proved usefulness of cell block method in diagnosis of intraocular lymphoma.
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 Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 02 Day
Last follow-up date
2016 Year 04 Month 26 Day
Date of closure to data entry
2017 Year 02 Month 26 Day
Date trial data considered complete
2017 Year 02 Month 26 Day
Date analysis concluded
2017 Year 02 Month 26 Day

Other
Other related information Diagnostic efficacy seems to be favorable in cell block method in intraocular lymphoma.

Management information
Registered date
2016 Year 02 Month 04 Day
Last modified on
2017 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024089

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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