UMIN-CTR Clinical Trial

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	3000

Research contact person
Name of lead principal investigator	1st name (A) Norio Shimizu, (B) Sunao Sugita, Middle name Last name (C) Hiroshi Takase, (D) Satoko Nakano
Organization	(A)(C) Tokyo Medical and Dental University (B) RIKEN, Kobe Eye Center (D) Oita University
Division name	(D) Department of Ophthalmology
Zip code	879-5593
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 Satoko Middle name Last name Nakano
Organization	Oita University
Division name	Department of Ophthalmology
Zip code	879-5593
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(Kobe Eye Center), 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	Hokkaido University Health Sciences University of Hokkaido Tohoku University Gunma University University of Tsukuba Jichi Medical University Saitama Medical Center The University of Tokyo Tokyo Medical University University of Fukui Kyoto Prefectural University of Medicine Tottori University Yamaguchi University Ehime University Ishizuchi Eye Clnic Kochi University Kyushu University Miyata Ophthalmic Hospital University of Miyazaki Beijing Chaoyang Hospital, Capital Medical University Kresge Eye Institute University of Sao Paulo Universite Paris Descartes Shimadzu Corporation Tottori University University of Tsukuba Jichi Medical University Saitama Medical Center University of Miyazaki
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Oita University Hospital
Address	1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
Tel	097-586-6163
Email	gcrcjimu@oita-u.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

東京医科歯科大学(東京都) / Tokyo Medical and Dental University 理化学研究所・神戸アイセンター病院(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 いしづち眼科(愛媛県)/ Ishizuchi Eye Clnic 愛媛大学(愛媛県)/　Ehime University 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) 島津製作所(京都府)/　Shimadzu Corporation 鳥取大学(鳥取県)/　 Tottori University 筑波大学(茨城県)/　University of Tsukuba 自治医科大学さいたま医療センター(埼玉県)/　Jichi Medical University Saitama Medical Center 宮崎大学(宮崎県)/　University of Miyazaki

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	2015 Year 08 Month 28 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2025 Year 09 Month 30 Day
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	2020 Year 10 Month 08 Day

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