UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006110 |
|---|---|
| Receipt number | R000007229 |
| Scientific Title | Development and application of the new clinical laboratory procedure using saliva - For the prevebtion of pneumonia - |
| Date of disclosure of the study information | 2011/08/22 |
| Last modified on | 2011/08/03 18:45:35 |
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Basic information
Public title
Development and application of the new clinical laboratory procedure using saliva - For the prevebtion of pneumonia -
Acronym
Development and application of the new clinical laboratory procedure using saliva - For the prevebtion of pneumonia -
Scientific Title
Development and application of the new clinical laboratory procedure using saliva - For the prevebtion of pneumonia -
Scientific Title:Acronym
Development and application of the new clinical laboratory procedure using saliva - For the prevebtion of pneumonia -
Region
| Japan |
Condition
Condition
pneumonia,inflammatory disease
Classification by specialty
| Geriatrics | Pediatrics | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study develops the new laboratory procedure using saliva which has not been utilized well as the clinical specimens until now and aims at the prevention and the early detection of senile pneumonia and inflammation of the infant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Correlation of the CRP concentration between saliva and blood
2)Evaluation of CRP concentration in saliva as inflammatory marker
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy person volunteer
2) Patients who had a diagnosis of inflammatory disease
Key exclusion criteria
1) Patients and volunteers who do not agree to participant in this trial.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Shirakawa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of biophysics
Zip code
Address
7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
078-796-4541
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Shirakawa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of biophysics
Zip code
Address
7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
078-796-4541
Homepage URL
sirakawa@rabbit.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2011 | Year | 08 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
randum sample
prospective examination
Management information
Registered date
| 2011 | Year | 08 | Month | 03 | Day |
Last modified on
| 2011 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007229
