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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021491
Receipt No. 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

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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
Email 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
Email tochimarumi@yahoo.co.jp

Sponsor
Institute School of Medicine, Fukuoka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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