UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012087 |
|---|---|
| Receipt number | R000014024 |
| Scientific Title | Clinical evaluation of Norovirus detection on the BD MAXTM system |
| Date of disclosure of the study information | 2013/10/21 |
| Last modified on | 2015/12/07 15:11:10 |
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Basic information
Public title
Clinical evaluation of Norovirus detection on the BD MAXTM system
Acronym
Clinical evaluation of Norovirus detection on the BD MAXTM system
Scientific Title
Clinical evaluation of Norovirus detection on the BD MAXTM system
Scientific Title:Acronym
Clinical evaluation of Norovirus detection on the BD MAXTM system
Region
| Japan |
Condition
Condition
Norovirus
Classification by specialty
| Medicine in general | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficiency of RT-PCR in detection of Norovirus from patients with diarrhea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of BD MAXTM system compared with RT-PCR
Key secondary outcomes
Sensitivity and specificity of EIA compared with RT-PCR
Sensitivity and specificity of immunochromatography compared with RT-PCR
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have liquid or soft stool at least 3 times a day
Patients who are 20 years or older
Patients with written informed consent
Key exclusion criteria
Patients with stomas
Patients who are recognized as not applicable by a study investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Naito |
Organization
Juntendo University School of Medicine
Division name
Department of General Medicine
Zip code
Address
3-1-1 Hongo, Bunkyo-ku,Tokyo
TEL
03-3813-3111
naito@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Hosoda |
Organization
Juntendo University School of Medicine
Division name
Department of General Medicine
Zip code
Address
3-1-1 Hongo, Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
ottoto723@gmail.com
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, 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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 21 | 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
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Random sample
Detection of Norovirus
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014024
