UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036915 |
|---|---|
| Receipt number | R000042068 |
| Scientific Title | Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2022/12/05 19:00:07 |
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Basic information
Public title
Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases
Acronym
Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases
Scientific Title
Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases
Scientific Title:Acronym
Comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases
Region
| Japan |
Condition
Condition
infectious eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of comprehensive polymerase chain reaction system for diagnosis of ocular infectious diseases
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
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
comprehensive polymerase chai reaction system
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 infectious eye disease, and also who gave us the a 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
100
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Hasegawa |
Organization
Tsukuba university
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba-city, Ibaraki, Japan
TEL
029-853-3148
ytamura-tuk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hasegawa |
Organization
Tsukuba university
Division name
Department of Ophthalmology, Faculty of Medicine,
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba-city, Ibaraki, Japan
TEL
029-853-3148
Homepage URL
ytamura-tuk@umin.ac.jp
Sponsor or person
Institute
Tsukuba university
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University
Address
1-1-1Tennoudai Tsukuba-city, Ibaraki, Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2019 | 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
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
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042068
