UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021491 |
|---|---|
| Receipt number | R000024701 |
| Scientific Title | Evaluation of a highly sensitive immunochromatography system for rapid diagnosis of epidemic keratoconjunctivitis. |
| Date of disclosure of the study information | 2016/03/20 |
| Last modified on | 2016/03/16 13:27:56 |
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Basic information
Public title
Evaluation of a highly sensitive immunochromatography system for rapid diagnosis of epidemic keratoconjunctivitis.
Acronym
Highly sensitive immunochromatography system
Scientific Title
Evaluation of a highly sensitive immunochromatography system for rapid diagnosis of epidemic keratoconjunctivitis.
Scientific Title:Acronym
Highly sensitive immunochromatography system
Region
| Japan |
Condition
Condition
Epidermic keratoconjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study proves the efficacy of using tear specimens with the highly sensitive immunochromatography system compared with existing adenovirus antigen test of conjunctival scraping.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study is assessed by the correlation of concordance rates (positive rate, negative rate) of the results compared the highly sensitive immunochromatography using tear specimens with the existing adenovirus antigen test using conjunctival scraping. Assessment is evaluated promptly after testing.
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
Patient is generally examined once.
Examination period is not settled.
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are listed as below: 1}presence of clinical findings at least one as following: 1)conjunctival injection, 2)palpebral edema, 3)discharge, 4)epiphora, 5)ophthalmalgia; 2} those who is diagnosed by adenovirus antigen test; 3} those from whom consent is obtained.
Key exclusion criteria
Exclusion criteria are following: 1) specimens cannot be collected in a sufficient amount; 2) those who is not fitted with this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Uchio |
Organization
School of Medicine, Fukuoka University
Division name
Department of Ophthalmology
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
euchio@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Tsukahara-Kawamura |
Organization
School of Medicine,, Fukuoka University
Division name
Department of Ophthalmology
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
tochimarumi@yahoo.co.jp
Sponsor or person
Institute
School of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
MIZUHO MEDY Co 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 20 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024701
| 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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