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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019201
Receipt No. R000022196
Scientific Title New multiplex PCR strip for comprehensive diagnosis of infectious eye disease : multicenter prospective study
Date of disclosure of the study information 2015/10/01
Last modified on 2018/10/30

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Basic information
Public title New multiplex PCR strip for comprehensive diagnosis of infectious eye disease : multicenter prospective study
Acronym New multiplex PCR strip for comprehensive diagnosis of infectious eye disease : multicenter prospective study
Scientific Title New multiplex PCR strip for comprehensive diagnosis of infectious eye disease : multicenter prospective study
Scientific Title:Acronym New multiplex PCR strip for comprehensive diagnosis of infectious eye disease : multicenter prospective study
Region
Japan Asia(except Japan) North America
South America Europe

Condition
Condition Infectious eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of new multiplex PCR strip for infectious eye disease
Basic objectives2 Others
Basic objectives -Others Positive predictive value
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive predictive value
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 Patients suspected of having t infectious eye disease and controls, and also who gave us the agreement with the aim of this clinical trial.
Key exclusion criteria Patients who is determined inappropriate to participate in the study by the attending physician
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name (A) Norio Shimizu, (B) Sunao Sugita, (C) Hiroshi Takase, (D) Satoko Nakano
Organization (A)(C) Tokyo Medical and Dental University
(B) RIKEN
(D) Oita University
Division name (D) Department of Ophthalmology
Zip code
Address (D) 1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
TEL 097-586-5904
Email snakano-oph@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Nakano
Organization Oita University
Division name Department of Ophthalmology
Zip code
Address 1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
TEL 097-586-5904
Homepage URL
Email snakano-oph@umin.ac.jp

Sponsor
Institute Tokyo Med and Dent University, RIKEN, Oita University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Gunma University Graduate School of Medicine
Kyushu University
Yamaguchi University Graduate School of Medicine
Kyoto Prefectural University of Medicine
The University of Tokyo Hospital
Tokyo Medical University
Kochi University School of Medicine
Tohoku University Graduate School of Medicine
Hokkaido University Graduate School of Medicine
Miyata Eye Hospital
University of Fukui
Health Sciences University of Hokkaido
Toho University Omori Medical Center
Beijing Chaoyang Hospital, Capital Medical University
Kresge Eye Institute
University of Sao Paulo
Universite Paris Descartes
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 東京医科歯科大学(東京都) / Tokyo Medical and Dental University
理化学研究所(兵庫県) / RIKEN
大分大学(大分県) / Oita University
北海道大学(北海道) / Hokkaido University
北海道医療大学(北海道) / Health Sciences University of Hokkaido
東北大学(宮城県) / Tohoku University
群馬大学(群馬県) / Gunma University
東京大学(東京都) / The University of Tokyo
京都府立医科大学(京都府) / Kyoto Prefectural University of Medicine
山口大学(山口県) / Yamaguchi University
高知大学(高知県) / Kochi University
九州大学(福岡県) / Kyushu University
宮田眼科病院(宮崎県) / Miyata Ophthalmic Hospital
東京医科大学(東京都) / Tokyo Medical University
福井大学(福井県) / University of Fukui
東邦大学医療センター大森病院 / Toho University Omori Medical Center
Beijing Chaoyang Hospital, Capital Medical University (Beijing, China)
Kresge Eye Institute (Detroit, Michigan, U.S.A)
University of Sao Paulo (Sao Paulo, Brazil)
Universite Paris Descartes (Paris, France)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 01 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
2015 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
Multicenter prospective study

Recruitment of Subject:
All patients who visit our institute since October 2015 and meet the inclusion/exclusion criteria .

Primary outcome:
Evaluation of new multiplex PCR strip for infectious eye disease (Positive predictive value)

Management information
Registered date
2015 Year 10 Month 01 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022196

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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