UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027952 |
|---|---|
| Receipt number | R000032021 |
| Scientific Title | Research on the evaluation of adenovirus antigen detection kit |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/06/27 15:54:52 |
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Basic information
Public title
Research on the evaluation of adenovirus antigen detection kit
Acronym
Evaluation of adenovirus detection kit
Scientific Title
Research on the evaluation of adenovirus antigen detection kit
Scientific Title:Acronym
Evaluation of adenovirus detection kit
Region
| Japan |
Condition
Condition
epidemic keratoconjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of a novel adenovirus antigen detection kit on epidemic keratoconjunctivitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the sensitivity and specificity of novel and current kits on adenovirus PCR positivity
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Viral sampling by conjunctival scrapings
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with acute conjunctivitis diagnosed clinically as epidemic keratoconjunctivitis
Key exclusion criteria
Cases who reject to join this clinical research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Uchio |
Organization
Fukuoka University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-45-1 Nanakuma, Jonan, Fukuoka, Japan
TEL
0928011011
euchio@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiko Matsuda |
Organization
Wako Pure Chemical Industries, Ltd.
Division name
Division of Clinical Test Development
Zip code
Address
3-1-2 Doshomachi, Chuo, Osaka
TEL
0662032392
Homepage URL
matsuda.eiko@wako-chem.co.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Wako Pure Chemical Industries. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
福岡大学病院（福岡県），小沢眼科医院（福岡県），こにし眼科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 27 | Day |
Last modified on
| 2017 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032021
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
