UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019602 |
|---|---|
| Receipt number | R000021747 |
| Scientific Title | Comparison between new test (NTa08) and conventional test (Quick chaser Adeno) for detection of Adenovirus antigen in epidemic keratoconjunctivitis and pharyngoconjunctivalfever |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2018/10/18 10:09:05 |
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Basic information
Public title
Comparison between new test (NTa08) and conventional test (Quick chaser Adeno) for detection of Adenovirus antigen in epidemic keratoconjunctivitis and pharyngoconjunctivalfever
Acronym
Detection of Adenovirus antigen using NTa08 in conjunctivatitis
Scientific Title
Comparison between new test (NTa08) and conventional test (Quick chaser Adeno) for detection of Adenovirus antigen in epidemic keratoconjunctivitis and pharyngoconjunctivalfever
Scientific Title:Acronym
Detection of Adenovirus antigen using NTa08 in conjunctivatitis
Region
| Japan |
Condition
Condition
Epidemic kerato-conjunctivitis
Pharyngo-conjunctival fever
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When this new diagnostic medicine (NTa08) is compared with conventional kits, It is not have to chafe eyes hard, so patient's burden can be reduced, also operational simplification can be expected.
The concordance rate is verified from a judgment result using existence diagnostic medicine and PCR.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Check the positive and negative of the new diagnostic medicine by using the existing diagnostic medicine and PCR, to verify the match rate from the judgment result.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Check using new diagnostic test(NTa08)
Interventions/Control_2
Check using conventional kits
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
Patient suspected of adenovirus infection.
Key exclusion criteria
The person who judged that a test responsibility doctor was disqualified as a target of the final examination.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Shiraishi |
Organization
Ehime University graduate school
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa Toon-shi Ehime Japan
TEL
089-960-5361
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Ehime University graduate school
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa Toon-shi Ehime Japan
TEL
089-960-5361
Homepage URL
https://www.ehime-u.ac.jp/
t-suzuki@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University graduate school, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Nitto medic corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛媛大学医学部附属病院（愛媛県）/
Ehime University, Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021747
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
