UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050986 |
|---|---|
| Receipt number | R000058035 |
| Scientific Title | Clinical Performance of a Multiplex Solid-Phase Real-Time Polymerase Chain Reaction Test for Infectious Uveitis |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/05/31 18:25:53 |
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Basic information
Public title
Clinical Performance of a Multiplex Solid-Phase Real-Time Polymerase Chain Reaction Test for Infectious Uveitis
Acronym
Clinical Performance of a Multiplex Solid-Phase Real-Time Polymerase Chain Reaction Test for Infectious Uveitis
Scientific Title
Clinical Performance of a Multiplex Solid-Phase Real-Time Polymerase Chain Reaction Test for Infectious Uveitis
Scientific Title:Acronym
Clinical Performance of a Multiplex Solid-Phase Real-Time Polymerase Chain Reaction Test for Infectious Uveitis
Region
| Japan |
Condition
Condition
Infectious Uveitis, Non-infectious Uveitis, Non-uveitis (including suspicion)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the results of multiplex solid-phase real-time polymerase chain reaction Test and control in the detection of nucleic acids of the main pathogens of infectious uveitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance rate (All pathogens)
Key secondary outcomes
Concordance rate (pathogen-specific), Correlation of DNA copy number
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
Infectious Uveitis, Non-infectious Uveitis, Non-uveitis (including suspicion)
Key exclusion criteria
Patient who are judged ineligible by principal investigator and co-investigator
Sample volume < 20uL
Samples including hemorrhage or solid substance
Target sample size
160
Research contact person
Name of lead principal investigator
| 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
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
Oita University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita 879-5593, Japan
Tel
097-586-6380
rinrikenkyu@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
旭川医科大学病院（北海道）、北海道大学病院（北海道）、東北大学病院（宮城県）、筑波大学附属病院（茨城県）、埼玉医科大学病院（埼玉県）、自治医科大学附属さいたま医療センター（埼玉県）、杏林大学医学部付属病院（東京都）、東京医科大学病院（東京都）、東京医科歯科大学病院（東京都）、国立国際医療研究センター（東京都）、横浜市立大学附属病院（神奈川県）、富山大学附属病院（富山県）、福井大学医学部附属病院（福井県）、信州大学医学部附属病院（長野県）、名古屋大学医学部附属病院（愛知県）、京都府立医科大学附属病院（京都府）、大阪大学医学部附属病院（大阪府）、近畿大学病院（大阪府）、関西医科大学附属病院（大阪府）、JCHO大阪病院（大阪府）、淀川キリスト教病院（大阪府）、神戸大学医学部附属病院（兵庫県）、神戸市立神戸アイセンター病院（兵庫県）、鳥取大学医学部附属病院（鳥取県）、島根大学医学部附属病院（島根県）、広島大学病院（広島県）、山口大学医学部附属病院（山口県）、徳島大学病院（徳島県）、愛媛大学病院（愛媛県）、高知大学医学部附属病院（高知県）、九州大学病院（福岡県）、福岡大学病院（福岡県）、大分大学（大分県）、別府医療センター（大分県）、宮崎大学医学部附属病院（宮崎県）、宮田眼科病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
475
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058035
