UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019201 |
|---|---|
| Receipt number | 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 | 2020/10/08 16:15:41 |
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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
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
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
snakano-oph@umin.ac.jp
Sponsor or person
Institute
Tokyo Med and Dent University, RIKEN(Kobe Eye Center), Oita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022196
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
